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A record, in full

FDA recalls unified (food + drug + device)

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GET /v1/datafloe/fda-recalls

FDA recalls unified (food + drug + device)

source openFDA — food + drug + device enforcement  ·  license CC0 1.0 (public domain)  ·  retrieved 2026-08-04
redistribution unrestricted, commercial use permitted, no attribution required
rows86,770
columns21
version2026-08-04
sourcelicensed
License CC0 public domain CLEARED FOR REUSE · REC 2026-08

Schema

columntypenull %
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 2.8
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

idrecall_numberevent_idproduct_typestatusclassificationrecalling_firmcitystatecountrypostal_codevoluntary_mandatedinitial_firm_notificationdistribution_patternproduct_descriptionproduct_quantityreason_for_recallcode_inforecall_initiation_datecenter_classification_datereport_date
86769Z-2749-202699290DevicesOngoingIMedline Industries, LPNorthfieldILUnited States60093-2753Voluntary: Firm initiatedTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, VisitUS: OH, CA, IL, IN, FL, SC, AZ, NJ.MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J; 6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K; 7) TOTAL HIP, Medline Kit SKU DYNJ906665G; 8) TOTAL KNEE, Medline Kit SKU DYNJ906666J; 9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A; 10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A; 11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B; 12) TOTAL JOINT, Medline Kit SKU DYNJ909069B; 13) TOTAL KNEE, Medline Kit SKU DYNJ909070C; 14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B; 15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C; 16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534; 17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A; 18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B; 19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F; 20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D; 21) TOTAL KNEE, Medline Kit SKU DYNJ909643D; 22) TOTAL KNEE, Medline Kit SKU DYNJ909643F; 23) TOTAL JOINT, Medline Kit SKU DYNJ910002A; 24) TOTAL KNEE, Medline Kit SKU DYNJ910354A; 25) TOTAL HIP, Medline Kit SKU DYNJ910813; 26) ANTERIOR HIP, Medline Kit SKU DYNJ911083.2301 kitsMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25ELB079; Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25DLA930; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25IBN992; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25HBS205; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25DBH984; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25CBB436; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25ABR220; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 24LBI991; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBR847; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBE741; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 25ADA380; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 24KDA993; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA748; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA157; Medline Kit SKU DYNJ903493K, UDI/DI 10198459293122 (each) 40198459293123 (case), Kit Lot Number 25DDA444; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25GDA109; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25FDB471; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25EDB817; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25BDA465; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDB209; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDA032; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24KDB063; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 25ABU735; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 24LBU076; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25EBN666; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25DBF470; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25CBA048; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25FBH718; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25EBF688; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25DBO198; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25ABL694; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 24KBU683; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 25ABI346; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBR150; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBD242; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25EBM976; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25CBJ024; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25BBA740; Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25EBQ769; Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25CBU372; Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 25ABF133; Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 24LBD821; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25FBA422; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25DBS695; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBV173; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBG902; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25BBN621; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 25ABV657; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO734; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO776; Medline Kit SKU DYNJ909534A, UDI/DI 10198459273209 (each) 40198459273200 (case), Kit Lot Number 25CBF686; Medline Kit SKU DYNJ909534B, UDI/DI 10198459527814 (each) 40198459527815 (case), Kit Lot Number 25JBN131; Medline Kit SKU DYNJ909640F, UDI/DI 10198459250057 (each) 40198459250058 (case), Kit Lot Number 25DBD310; Medline Kit SKU DYNJ909642D, UDI/DI 10198459250040 (each) 40198459250041 (case), Kit Lot Number 25HBR652; Medline Kit SKU DYNJ909643D, UDI/DI 10198459250064 (each) 40198459250065 (case), Kit Lot Number 25DBB386; Medline Kit SKU DYNJ909643F, UDI/DI 10198459392603 (each) 40198459392604 (case), Kit Lot Number 25HBU964; Medline Kit SKU DYNJ910002A, UDI/DI 10198459073335 (each) 40198459073336 (case), Kit Lot Number 25DBH861; Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25DBF544; Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25CBM051; Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBU686; Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBF765; Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25DBK837; Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25CBN099.2026-06-052026-07-222026-07-29
86768Z-2756-202699252DevicesOngoingIIBoston Scientific CorporationSaint PaulMNUnited States55112-5700Voluntary: Firm initiatedLetterGlobal Distribution. US Nationwide.FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01508,151 unitsBoston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.UDI-DI: 00191506043131; Lots: CL12695, CL12696, CL12699, CL12700, CL12703, CL12808, CL12816, CL12817, CL12823, CL12834, CL12835, CL12836, CL12853, CL12860, CL12882, CL12883, CL12884, CL12891, CL12907, CL12908, CL12909, CL12919, CL12949, CL12950, CL12969, CL12976, CL12979, CL12980, CL13005, CL13010, CL13011, CL13012, CL13018, CL13032, CL13033, CL13034, CL13037, CL13056, CL13057, CL13058, CL13074, CL13075, CL13076, CL13077, CL13097, CL13098, CL13099, CL13100, CL13104, CL13115, CL13116, CL13117, CL13118, CL13119, CL13135, CL13136, CL13137, CL13138, CL13139, CL13156, CL13157, CL13191, CL13192, CL13193, CL13194, CL13197, CL13208, CL13209, CL13210, CL13215, CL13216, CL13217, CL13224, CL13229, CL13230, CL13257, CL13258, CL13288, CL13289, CL13337, CL13338, CL13365, CL13366, CL13384, CL13398, CL13399, CL13419, CL13420, CL13423, CL13467, CL13469, CL13470, CL13471, CL13472, CL13517, CL13525, CL13526, CL13527, CL13528, CL13535, CL13536, CL13541, CL13550, CL13551, CL13552, CL13553, CL13555, CL13564, CL13565, CL13566, CL13571, CL13574, CL13575, CL13576, CL13598, CL13599, CL13616, CL13637, CL13642, CL13643, CL13644, CL13665, CL13666, CL13667, CL13668, CL13704, CL13705, CL13706, CL13715, CL13716, CL13721, CL13734, CL13735, CL13736, CL13761, CL13762, CL13763, CL13798, CL13799, CL13800, CL13822, CL13825, CL13826, CL13835, CL13836, CL13837, CL13858, CL13859, CL13860, CL13912, CL13913, CL13914, CL13927, CL13928, CL13929, CL13942, CL13944, CL13945, CL13974, CL13975, CL13981, CL13990, CL13991, CL13992, CL14027, CL14028, CL14029, CL14040, CL14041, CL14042, CL14053, CL14054, CL14055, CL14079, CL14080, CL14081, CL14122, CL14123, CL14124, CL14139, CL14140, CL14141, CL14169, CL14172, CL14173, CL14174, CL14188, CL14189, CL14190, CL14227, CL14228, CL14229, CL14250, CL14251, CL14252, CL14288, CL14289, CL14290, CL14347, CL14348, CL14377, CL14378, CL14398, CL14399, CL14400, CL14440, CL14441, CL14442, CL14489, CL14490, CL14492, CL14493, CL14496, CL14502, CL14505, CL14506, CL14520, CL14583, CL14584, CL14585, CL14634, CL14636, CL14637, CL14671, CL14672, CL14673, CL14674, CL14698, CL14699, CL14700, CL14712, CL14713, CL14714, CL14715, CL14751, CL14752, CL14753, CL14771, CL14772, CL14773, CL14774, CL14815, CL14816, CL14817, CL14818, CL14856, CL14857, CL14858, CL14859, CL14872, CL14873, CL14874, CL14930, CL14931, CL14932, CL14936, CL14937, CL14938, CL14970, CL14971, CL14972, CL15006, CL15007, CL15010, CL15011, CL15068, CL15069, CL15070, CL15080, CL15089, CL15110, CL15130, CL15131, CL15132, CL15194, CL15195, CL15196, CL15241, CL15242, CL15243, CL15273, CL15274, CL15275, CL15276, CL15319, CL15320, CL15321, CL15322, CL15359, CL15360, CL15361, CL15362, CL15398, CL15399, CL15400, CL15401, CL15428, CL15429, CL15430, CL15431, CL15451, CL15475, CL15476, CL15477, CL15491, CL15492, CL15493, CL15494, CL15525, CL15540, CL15541, CL15548, CL15549, CL15570, CL15583, CL15584, CL15599, CL15603, CL15617, CL15641, CL15642, CL15718, CL15756, CL15769, CL15770, CL157772026-06-112026-07-172026-07-29
86766Z-2757-202699252DevicesOngoingIIBoston Scientific CorporationSaint PaulMNUnited States55112-5700Voluntary: Firm initiatedLetterGlobal Distribution. US Nationwide.FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01193,000 unitsBoston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.UDI-DI: 00191506042516; Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103, CL13122, CL13123, CL13142, CL13160, CL13196, CL13212, CL13219, CL13231, CL13260, CL13291, CL13340, CL13375, CL13401, CL13422, CL13468, CL13519, CL13573, CL13578, CL13614, CL13646, CL13670, CL13671, CL13708, CL13719, CL13722, CL13732, CL13760, CL13801, CL13802, CL13820, CL13833, CL13856, CL13910, CL13911, CL13925, CL13940, CL13971, CL13972, CL13988, CL14025, CL14039, CL14050, CL14051, CL14076, CL14077, CL14119, CL14120, CL14135, CL14137, CL14171, CL14187, CL14226, CL14249, CL14286, CL14287, CL14345, CL14346, CL14375, CL14376, CL14396, CL14397, CL14439, CL14488, CL14500, CL14501, CL14518, CL14519, CL14581, CL14582, CL14633, CL14635, CL14670, CL14697, CL14711, CL14749, CL14750, CL14769, CL14770, CL14813, CL14814, CL14854, CL14855, CL14870, CL14871, CL14928, CL14929, CL14933, CL14934, CL14935, CL14968, CL14969, CL15005, CL15009, CL15067, CL15107, CL15108, CL15109, CL15128, CL15129, CL15191, CL15192, CL15193, CL15239, CL15240, CL15272, CL15318, CL15358, CL15397, CL15427, CL15474, CL15490, CL15539, CL15568, CL15569, CL15597, CL15598, CL15637, CL15638, CL15640, CL15754, CL15755, CL15775, CL15776, CL158082026-06-112026-07-172026-07-29
86765Z-2783-202699301DevicesOngoingIIMedline Industries, LPNorthfieldILUnited States60093-2753Voluntary: Firm initiatedLetterUS Nationwide distribution in the states of CA, FL, MD. PA, and TX.Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B980 kitsAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL8892026-06-082026-07-232026-07-29
86764Z-2764-202699297DevicesOngoingIMedline Industries, LPNorthfieldILUnited States60093-2753Voluntary: Firm initiatedTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, VisitUS: Mo, CO, ILMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N52 kitsThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.2026-06-082026-07-222026-07-29

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": "2026-08-04",
    "content_hash": "sha256:204357192074a1bbafc2a2184b60837296c9bde574f9941c902c7d54ee322361",
    "published_at": "2026-08-04"
  },
  "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.