A record, in full
FDA recalls unified (food + drug + device)
Schema, a real sample, a live query box, snippets, and the machine-readable license.
FDA recalls unified (food + drug + device)
source openFDA — food + drug + device enforcement ·
license CC0 1.0 (public domain) ·
retrieved 2026-10-06
redistribution unrestricted, commercial use permitted, no attribution required
redistribution unrestricted, commercial use permitted, no attribution required
Schema
| column | type | null % |
|---|---|---|
| id | integer | 0.0 |
| recall_number | text | 0.0 |
| event_id | text | 0.0 |
| product_type | text | 0.0 |
| status | text | 0.0 |
| classification | text | 0.0 |
| recalling_firm | text | 0.0 |
| city | text | 0.0 |
| state | text | 2.9 |
| country | text | 0.0 |
| postal_code | text | 0.0 |
| voluntary_mandated | text | 0.0 |
| initial_firm_notification | text | 0.6 |
| distribution_pattern | text | 0.0 |
| product_description | text | 0.0 |
| product_quantity | text | 2.1 |
| reason_for_recall | text | 0.1 |
| code_info | text | 0.1 |
| recall_initiation_date | date | 0.0 |
| center_classification_date | date | 0.0 |
| report_date | date | 0.0 |
Sample · 5 rows
| id | recall_number | event_id | product_type | status | classification | recalling_firm | city | state | country | postal_code | voluntary_mandated | initial_firm_notification | distribution_pattern | product_description | product_quantity | reason_for_recall | code_info | recall_initiation_date | center_classification_date | report_date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 87583 | Z-3243-2026 | 99769 | Devices | Ongoing | II | Philips North America Llc | Cambridge | MA | United States | 02141-2289 | Voluntary: Firm initiated | Letter | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia; | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X); | 965 | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. | 1. Model Number (System): 781260 (1.5T) UDI-DI: 884838095076; Serial Numbers: 32953, 8750, 8554, 9013, 18574, 18801, 18988, 20211, 32923, 32778, 8156, 8752, 10139, 10164, 21379, 21175, 32445, 11100, 18583, 18746, 18761, 18853, 18965, 18986, 20003, 21138, 21349, 21384, 21748, 22144, 22266, 30037, 30139, 30146, 32223, 32458, 33044, 33045, 33220, 33246, 33716, 72250, 5572, 8240, 8734, 8808, 8985, 10183, 12030, 20282, 21466, 32643, 8713, 8917, 10087, 10130, 18673, 18701, 18803, 32283, 22220, 8087, 8215, 8923, 13026, 22127, 32467, 8427, 10528, 8862, 21333, 21710, 21768, 22255, 22256, 22257, 21554, 22070, 32049, 5425, 5447, 5484, 5536, 5539, 5550, 8001, 8084, 8096, 8110, 8175, 8263, 8315, 8318, 8321, 8387, 8401, 8407, 8476, 8486, 8559, 8601, 8611, 8642, 8704, 8804, 8885, 9020, 9024, 10008, 10033, 10061, 10075, 10117, 10170, 10174, 10191, 10717, 11000, 11031, 11062, 11102, 11108, 12121, 18013, 18565, 18631, 18690, 18697, 18894, 18906, 18938, 18957, 20057, 20070, 20160, 21015, 21018, 21020, 21082, 21453, 21814, 21932, 21979, 22194, 30097, 32099, 32134, 32163, 32164, 32176, 32333, 32334, 32340, 32341, 32454, 32636, 32710, 32752, 39018, 39031, 39103, 5499, 5505, 8657, 21296, 32680, 10029, 18987, 8054, 8350, 11064, 11072, 12053, 13011, 18575, 18718, 18720, 18940, 20032, 20055, 20206, 20295, 21004, 21087, 21091, 21141, 21184, 21200, 21210, 21223, 21247, 21261, 21312, 21347, 21451, 21555, 21576, 21582, 21611, 21680, 21691, 21694, 21737, 21739, 21755, 21863, 21878, 21912, 21942, 22017, 22018, 22086, 22093, 22103, 22171, 22240, 30132, 30239, 32140, 32158, 32285, 32441, 32449, 32822, 33023, 33051, 33106, 33126, 33179, 39005, 72081, 8213, 5466, 5537, 5546, 8045, 8311, 8395, 8424, 8431, 8641, 8667, 8712, 8786, 8840, 10102, 10185, 10220, 10457, 10552, 10554, 11017, 11046, 12036, 13001, 18069, 18101, 18509, 18511, 18548, 18655, 18788, 18970, 20111, 20132, 20165, 20196, 20413, 21032, 21362, 21551, 21565, 21623, 21746, 21809, 21890, 21892, 22044, 22055, 22182, 22296, 22299, 30033, 32264, 32316, 32478, 32492, 32506, 32670, 32805, 32849, 32990, 33100, 39037, 72239, 72243, 5511, 8012, 8057, 8060, 8094, 8309, 8481, 8517, 8531, 8561, 8711, 8724, 8843, 8857, 8887, 8896, 8949, 10007, 10151, 10498, 10513, 10719, 10906, 10913, 11005, 11042, 11091, 12055, 12114, 12120, 13029, 13046, 13047, 13062, 13073, 18017, 18107, 18524, 18670, 18704, 18929, 18954, 20002, 20011, 20035, 20187, 20195, 20209, 20237, 20263, 20278, 20288, 20302, 21089, 21129, 21182, 21209, 21213, 21222, 21249, 21278, 21326, 21355, 21403, 21448, 21482, 21519, 21560, 21579, 21583, 21640, 21697, 21759, 21780, 21792, 21969, 21987, 22013, 22031, 22098, 22123, 22157, 22175, 22184, 32132, 32217, 32236, 32258, 39009, 21804, 13069, 33352, 22237, 33062, 8091, 10230, 11022, 12169, 18610, 18800, 18948, 21067, 21481, 32709, 33215, 8639, 8686, 18663, 18699, 21019, 21023, 21359, 32119, 32742, 8086, 8292, 10543, 21591, 22189, 32573, 32145, 21994, 21995, 10086, 10556, 8983, 18985, 8166, 8723, 10161, 10530, 22301, 22342, 32391, 8168, 8451, 21498, 18512, 21929, 22152, 21143, 21612, 22233, 22273, 22285, 8616, 20112, 32311, 32513, 33198, 33366, 10570, 11018, 8354, 8694, 9006, 32200, 5479, 8485, 8550, 8746, 8779, 8799, 9032, 10461, 10716, 12047, 21133, 21294, 21577, 32839, 32845, 11085, 12134, 21438, 22100, 22137, 32094, 32147, 32221, 32296, 32374, 32405, 32059, 32180, 8392, 12115, 20182, 22107, 32359, 32245, 8492, 8895, 10079, 20151, 20152, 20198, 21084, 21454, 21880, 32807, 21880, 5475, 8100, 8352, 8560, 8578, 8630, 8760, 8772, 8835, 8906, 8971, 8975, 9001, 10036, 10196, 10482, 10703, 12033, 12034, 18558, 18726, 20226, 20303, 21108, 21290, 21664, 21665, 21788, 32131, 32174, 33385; 2. Model Number (System): 782112 (1.5T) UDI-DI: 884838098886; Serial Numbers: 18857, 21252, 21684, 30313, 32250, 8266, 8552, 18776, 21771, 21803, 22048, 30058, 30089, 32106, 32400, 32487, 32827, 32897, 33000, 33103, 33189, 33275, 33371, 33404, 33494, 33545, 33547, 33565, 33568, 33749, 33751, 18942, 20224, 21495, 21608, 21726, 22247, 32295, 32673, 32762, 33019, 32724, 30054, 32229, 32265, 32418, 32419, 32558, 32596, 32803, 33033, 33248, 33249, 33470, 33647, 72204, 72208, 22141, 8798, 10169, 10190, 10474, 10521, 12029, 13021, 13024, 18810, 21077, 21090, 21158, 21685, 21740, 22027, 39106, 8298, 18714, 18510, 32469, 21940, 32539, 8573, 10128, 18995, 20099, 20159, 21433, 21893, 22290, 32457, 32577, 32580, 32661, 32719, 32725, 32798, 33082, 75012, 8109, 8876, 10222, 18520, 18651, 18892, 18950, 20171, 21205, 21212, 21298, 21513, 21906, 21939, 22328, 32244, 32348, 32355, 32375, 22051, 22298, 30145, 32412, 32690, 33218, 33635, 33061, 8433, 18707, 30273, 32287, 32624, 33639, 32133, 21164, 32327, 33217, 10028, 21708, 13023, 21127, 21297, 33048, 72275, 32188, 32363, 32364, 32426, 22267, 22173, 32610, 32613, 32799, 32859, 32654, 39070, 21463, 32519, 33338, 10221, 20204, 39021, 22045; 3. Model Number (System): 782146 (1.5T) UDI-DI: 884838108691; Serial Numbers: 32679, 33002, 33480, 33570, 30308, 33611, 32251, 22251, 13013, 21990, 32407, 32683, 8935, 20414, 32116; 4. Model Number (System): 782145 (3.0T) UDI-DI: 884838108684; Serial Numbers: 34256, 38295, 74041, 34144, 17377, 38127, 38313, 73004, 23029, 24062, 34208, 17435, 38276; 5. Model Number (System): 781270 (XR and 3.0T) UDI-DI: 884838095083; Serial Numbers: 17536, 17212, 17508, 24013, 38184, 23011, 17290, 34060, 38366, 17434, 38013, 38109, 17302, 17429, 17006, 17378, 17386, 35073, 38062, 17533, 17590, 34111, 38235, 17204, 17292, 17339, 17415, 17416, 17436, 17447, 23030, 24055, 34032, 34142, 34145, 34152, 34211, 35044, 38037, 38040, 38192, 38202, 38317, 17247, 17265, 17268, 17286, 17353, 17367, 17389, 17425, 17509, 17517, 17572, 17580, 24022, 24036, 34001, 34058, 35020, 35078, 38001, 38020, 38135, 38224, 17524, 23026, 24095, 34083, 34107, 34236, 34249, 35060, 17222, 17242, 17245, 17250, 17299, 17308, 17342, 17357, 17388, 17399, 17493, 17499, 17556, 17559, 17564, 17594, 23034, 24047, 24109, 24110, 24111, 24117, 24134, 34036, 34090, 34096, 34221, 35027, 35046, 35048, 35053, 38005, 38006, 38015, 38032, 38041, 38161, 38168, 17344, 17495, 17570, 17615, 24020, 24133, 34067, 34076, 34292, 38263, 17428, 23036, 38026, 38131, 38134, 17550, 24145, 38217, 38225, 17237, 34250, 38138, 17352, 17274, 34037, 34080, 35047, 38116, 17326, 17172, 17490, 24007, 38126, 17356, 38111, 24107, 38065, 38259, 38300, 38023, 38102, 74011, 17206, 17240, 17284, 17313, 17375, 17459, 17516, 24058, 24076, 34019, 34223, 35019, 35031, 35040; 6. Model Number (System): 782113 (XR and 3.0T) UDI-DI: 884838098909; Serial Numbers: 17449, 17455, 24154, 17470, 34059, 34262, 34056, 24052, 38106, 38066, 38082, 24097, 34172, 38049, 38070, 38142, 17238, 17372, 24135, 34143, 38354, 74036, 35070, 34072, 35041, 38105, 17271, 17346, 24021, 24093, 24146, 34117, 34127, 34128, 34129, 34153, 34202, 35045, 35059, 38094, 38290, 38311, 38310, 17560, 38114, 38166, 38261, 38042, 38281, 34110, 38117, 17521, 38010, 34130, 34304, 38219, 38222, 17307, 38075, 17384, 17461; 7. Model Number (System): 782129 (XR and 3.0T) UDI-DI: 884838105805; Serial Numbers: 34055, 38195; 8. Model Number (System): 782118 (Ingenia Elition X) UDI-DI: 884838099746; Serial Numbers: 71019, 71025, 42072, 42054, 42194, 85676, 42113, 42085, 42049, 42098, 42158, 42159, 85655, 85665; 9. Model Number (System): 782144 (Ingenia Elition X); UDI-DI: 884838108677; Serial Numbers: 71278, 42250, 71508, 71366; | 2026-08-21 | 2026-09-18 | 2026-09-30 |
| 87579 | Z-3245-2026 | 99609 | Devices | Ongoing | II | Olympus Corporation of the Americas | Center Valley | PA | United States | 18034-8229 | Voluntary: Firm initiated | Letter | Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. | Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. | 105 units | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots. | 2026-08-19 | 2026-09-18 | 2026-09-30 |
| 87578 | Z-3255-2026 | 99710 | Devices | Ongoing | II | Cardinal Health 200, LLC | Waukegan | IL | United States | 60085-8337 | Voluntary: Firm initiated | Letter | US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX. | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15 | 9480 kits | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur. | 1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20 ; 2) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 3) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 4) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5129488 ; 5) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 6) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 7) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5182660 ; 8) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 9) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 10) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 11) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 12) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188102 ; 13) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5199118 ; 14) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 15) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 16) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5150160 ; 17) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 18) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5210853 ; 19) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5248375 ; 20) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5276968 ; 21) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 22) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5279226 ; 23) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 24) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5307185 ; 25) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5310701 ; 26) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 6051588 ; 27) PVMHIVM14, UDI-DI: 10198956165434(each), 50198956165432(case), Lot Number: 5126398 ; 28) PVMHIVM15, UDI-DI: 10198956184459(each), 50198956184457(case), Lot Number: 5129058 | 2026-08-10 | 2026-09-22 | 2026-09-30 |
| 87576 | Z-3241-2026 | 99769 | Devices | Ongoing | II | Philips North America Llc | Cambridge | MA | United States | 02141-2289 | Voluntary: Firm initiated | Letter | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia; | MR 5300 Model Number (REF): 1. 782110, 2. 782152; | 611 | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. | 1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636, 63638, 63666, 63668, 63675, 63687, 63689, 63690, 63695, 63696, 63729, 63730, 63742, 63763, 63765, 63774, 63787, 63806, 63829, 63686, 63193, 63257, 63431, 63583, 63592, 63123, 63155, 63474, 63576, 63416, 63748, 63337, 63456, 63046, 63157, 63357, 63569, 63000, 63325, 63504, 63506, 63104, 63110, 63115, 63186, 63248, 63250, 63252, 63343, 63344, 63586, 63785, 63820, 63821, 63328, 63664, 63771, 63457, 63070, 63356, 63011, 63013, 63022, 63028, 63083, 63095, 63107, 63202, 63292, 63365, 63432, 63490, 63499, 63500, 63594, 63031, 63217, 63219, 63220, 63221, 63271, 63309, 63025, 63125, 63211, 63451, 63508, 63541, 63559, 63623, 63745, 63019, 63034, 63058, 63084, 63168, 63218, 63374, 63443, 63510, 63057, 63063, 63493, 63513, 63564, 63612, 63684, 63719, 63812, 63366, 63372, 63026, 63074, 63093, 63099, 63109, 63111, 63112, 63130, 63169, 63175, 63176, 63177, 63178, 63188, 63210, 63223, 63224, 63228, 63229, 63240, 63312, 63333, 63341, 63342, 63389, 63408, 63413, 63428, 63466, 63483, 63487, 63523, 63531, 63532, 63533, 63557, 63566, 63567, 63571, 63596, 63598, 63602, 63614, 63618, 63619, 63632, 63650, 63665, 63672, 63673, 63677, 63732, 63749, 63035, 63041, 63043, 63047, 63062, 63090, 63100, 63128, 63136, 63140, 63141, 63150, 63152, 63160, 63162, 63172, 63173, 63182, 63222, 63238, 63244, 63253, 63258, 63363, 63367, 63370, 63393, 63394, 63126, 63323, 63558, 63080, 63699, 63514, 63388, 63410, 63411, 63723, 63311, 63375, 63507, 63159, 63396, 63122, 63068, 63433, 63001, 63784, 63679, 63409, 63756, 63762, 63434, 63259, 63379, 63277, 63301, 63187, 63464, 63758, 63759, 63098, 63134, 63326, 63355, 63418, 63561, 63562, 63624, 63032, 63036, 63069, 63139, 63437, 63438, 63439, 63610, 63700, 63708, 63709, 63710, 63733, 63738, 63746, 63786, 63103, 63164, 63534, 63563, 63589, 63631, 63127, 63603, 63720, 63482, 63489, 63494, 63498, 63547, 63555, 63106, 63108, 63402, 63475, 63698, 63775, 63776, 63822, 63825, 63273, 63424, 63626, 63397, 63398, 63445, 63006, 63008, 63009, 63015, 63016, 63024, 63030, 63042, 63044, 63049, 63053, 63105, 63135, 63138, 63151, 63153, 63154, 63492, 63352, 63059, 63497, 63681, 63488, 63503, 63722, 63071, 63072, 63294, 63295, 63296, 63297, 63299, 63340, 63361, 63455, 63519, 63724, 63770, 63067, 63174, 63191, 63197, 63449, 63674, 63800, 63798, 63039, 63165, 63318, 63330, 63380, 63440, 63012, 63014, 63018, 63029, 63033, 63087, 63196, 63203, 63204, 63316, 63520, 63587, 63477, 63530, 63740, 63201, 63400, 63401, 63446, 63453, 63478, 63502, 63550, 63597, 63605, 63616, 63704, 63747, 63757, 63780, 63823, 63824, 63833, 63119, 63442, 63461, 63570, 63766, 63767, 63810; 2. Model Number (REF): 782152; UDI-DI: N/A; Serial Numbers: 69304, 69349, 69098, 69101, 69250, 69318, 69321, 69338, 69238, 69239, 69024, 69026, 69034, 69039, 69046, 69081, 69083, 69105, 69151, 69235, 69023, 69037, 69041, 69066, 69112, 69152, 69233, 69302, 69299, 69193, 69194, 69241, 69287, 69320, 69070, 69071, 69106, 69110, 69127, 69161, 69360, 69366, 69044, 69045, 69048, 69116, 69286, 69300, 69351, 69055, 69073, 69075, 69086, 69191, 69207, 69243, 69252, 69258, 69260, 69261, 69262, 69264, 69268, 69270, 69288, 69290, 69295, 69296, 69297, 69000, 69003, 69008, 69010, 69011, 69014, 69015, 69017, 69030, 69147, 69312, 69325, 69326, 69327, 69328, 69329, 69330, 69331, 69332, 69333, 69334, 69289, 69340, 69115, 69200, 69201, 69263, 69154, 69342, 69348, 69170, 69135, 69139, 69197, 69271, 69277, 69133, 69185, 69215, 69234, 69038, 69189, 69053, 69058, 69065, 69078, 69085, 69092, 69103, 69122, 69123, 69169, 69177, 69179, 69216, 69220, 69221, 69224, 69225, 69228, 69229, 69267, 69301, 69305, 69306, 69307, 69313, 69314, 69323, 69343, 69365, 69316, 69027, 69096, 69097, 69186, 69212, 69240, 69254, 69255, 69063, 69064, 69069, 69080, 69095, 69126, 69176, 69315, 69005, 69067, 69175, 69198, 69247, 69294, 69298, 69336; | 2026-08-21 | 2026-09-18 | 2026-09-30 |
| 47577 | Z-3232-2026 | 99769 | Devices | Ongoing | II | Philips North America Llc | Cambridge | MA | United States | 02141-2289 | Voluntary: Firm initiated | Letter | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia; | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System); | 387 | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. | 1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215, 21397, 21431, 21689, 21986, 22021, 22243, 21427, 22117, 22326, 21076, 21104, 21183, 21264, 21272, 21284, 21321, 21334, 21351, 21405, 21455, 21479, 21494, 21508, 21572, 21574, 21589, 21666, 21776, 21805, 21868, 21879, 21935, 21957, 21968, 21993, 22001, 22004, 22066, 22130, 22136, 22155, 22207, 22258; 2. Model Numbers (REF): 781343 (Achieva 1.5T); UDI-DI: 884838055292; Serial Numbers: 72020, 72104, 72137, 72138, 72146, 72157, 72160, 72170, 72171, 72179, 72183, 72185, 72200, 72223, 72233, 72238, 72251, 72269, 72013, 72111, 72113, 72231, 72235, 72270, 72271, 72273, 72286, 72079, 72083, 72109, 72120, 72122, 72123, 72124, 72126, 72139, 72141, 72142, 72147, 72150, 72247, 72007, 72156, 72101, 72116, 72117, 72180, 72197, 72267, 72189, 72008, 72080, 72036, 72052, 72057, 72103, 72134, 72143, 72144, 72145, 72151, 72186, 72199, 72217, 72224, 72227, 72228, 72236, 72253, 72254, 72255, 72256, 72257, 72258, 72259, 72260, 72264, 72278, 72279, 72296, 72297, 72298, 72299, 72304, 72029, 72129, 72153, 72175, 72194, 72207, 72281, 72290, 72301, 72302, 72310, 72311, 72316, 72320, 72321, 72326, 72329, 72075, 72076, 72261, 72022, 72047, 72100, 72154, 72159, 72240, 72285, 72287, 72317, 72324, 72015, 72016, 72023, 72071, 72074, 72205, 72038, 72322, 72053, 72063, 72077, 72118, 72121, 72177, 72188, 72192, 72202, 72203, 72265, 72274, 72288, 72289, 72308, 72313, 72048, 72001, 72058, 72230, 72234, 72102, 72201, 72003, 72040, 72114, 72010, 72049, 72055, 72136, 72148, 72266, 72319, 72222, 72034, 72198, 72220, 72226, 72119, 72168, 72303, 72309, 72312, 72318, 72025, 72066, 72193, 72325, 72327, 72331, 72174, 72082, 72249; 3. Model Numbers (REF): 781283 (Achieva 1.5T Conversion); UDI-DI: N/A; Serial Numbers: 39056, 8989, 10126, 39098, 39108, 39004, 39010, 39028, 39032, 39086, 39094, 39095, 39058, 39091, 39105, 39053, 39073, 39067, 39016, 39025; 4. Model Numbers (REF): 781346 (Achieva 1.5 Conversion); UDI-DI: N/A; Serial Numbers: 18052, 8361, 8415, 10015, 75008, 5243, 8727, 10172, 10189, 10545, 18737, 75002, 75003, 75004, 75015, 8059, 8757, 8767, 8842, 8883, 8886, 8897, 8946, 8974, 8981, 8990, 10060, 18001, 18710, 75009, 75092, 75095, 75099, 75100, 8069, 8312, 8520, 10006, 10048, 18588, 75000, 75001, 75005, 75031, 75049, 75087, 8371, 8289, 8367, 8740, 10539, 75011, 8351, 8782, 8756, 75010, 75007, 8124, 8020; 5. Model Numbers (REF): 781178 (Achieva 1.5T Initial System); UDI-DI: N/A; Serial Numbers: 20095, 20056, 20230, 20258, 20085, 20094, 20113, 20050, 20072, 20088, 20096, 20252, 20281, 20297, 20307; | 2026-08-21 | 2026-09-18 | 2026-09-30 |
Query it — live
Use it
# every response carries x-license curl "https://api.datafloe.dev/v1/datafloe/fda-recalls?product_type=Food" \ -H "Authorization: Bearer datafloe_live_…"
const r = await fetch( "https://api.datafloe.dev/v1/datafloe/fda-recalls?product_type=Food", { headers: { Authorization: "Bearer datafloe_live_…" } } ); const { data, meta } = await r.json();
import httpx r = httpx.get( "https://api.datafloe.dev/v1/datafloe/fda-recalls", params={"product_type": "Food"}, headers={"Authorization": "Bearer datafloe_live_…"}, ) data = r.json()["data"]
License · machine-readable
{
"license_id": "cc0@1",
"spdx_analog": "CC0-1.0",
"rights": {
"commercial_use": true,
"redistribution": true,
"raw_download": true,
"ai_training": false
},
"attribution_required": false,
"attribution_text": "Source: openFDA (U.S. Food & Drug Administration), CC0 1.0. Do not rely on openFDA for medical decisions; results are unvalidated.",
"provenance": {
"uploader": "datafloe",
"declared_origin": "licensed",
"source_url": "https://open.fda.gov/license/",
"version": "2026-10-06",
"content_hash": "sha256:204357192074a1bbafc2a2184b60837296c9bde574f9941c902c7d54ee322361",
"published_at": "2026-10-06"
},
"price": {
"model": "free",
"monthly_usd": 0
},
"terms_url": "https://open.fda.gov/terms/"
} ai_training is false on every dataset by design — you learn we're license-explicit before training rights are ever sold.