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Recalls Safety

FDA Medical Device Recall Enforcement Dataset

FDA Medical Device Recall Enforcement Dataset

29,00 €

Download structured FDA medical-device recall enforcement records with the source export date, provenance and an explicit edition.

Purchase terms

Your purchase includes the edition described on this page. Later releases are separate unless this offer explicitly includes an update entitlement.

Source checks and new-release publication do not change the historical coverage or automatically add future editions to an earlier purchase.

Edition details

Edition
zf-033-2026-09-05-7c9764e97a00
Files
data/full.jsonl, data/full.csv, data/sample.json, schema.json, provenance.json, manifest.json, quality-report.json, LICENSE.md, README.md, CHANGELOG.md, sources/openfda-original.zip, sources/openfda-download-manifest.json, checksums.json
Formats
CSV, JSON, JSONL, MD, ZIP
Coverage
Complete device enforcement bulk export published by openFDA on 2026-08-27, containing 39,794 recall records.
Geographic scope
Complete device enforcement bulk export published by openFDA on 2026-08-27, containing 39,794 recall records.
Publisher
US FDA openFDA
Source updated
Explicitly unknown; see immutable provenance for the recorded source retrieval.
Source checked
2026-09-05T11:31:42.922227+00:00
Released
2026-09-05T11:31:42.922227+00:00
Licence and attribution
Source records remain subject to the original publisher terms linked in provenance.json. Retain attribution and source notices. Zentra grants use of the normalization, schema and packaging for internal and commercial analysis; this does not grant exclusive rights over public source facts or third-party material. No endorsement by source publishers.

View the publisher source

Schema

FieldTypeDescription
citystring
classificationstring
code_infostring
countrystring
distribution_patternstring
event_idstring
product_descriptionstring
product_quantitystring
product_typestring
reason_for_recallstring
recall_initiation_datestring
recall_numberstring
recalling_firmstring
report_datestring
source_urlstring
statestring
statusstring
termination_datenull|string

Sample preview

Open the public sample

cityclassificationcode_infocountrydistribution_patternevent_idproduct_descriptionproduct_quantityproduct_typereason_for_recallrecall_initiation_daterecall_numberrecalling_firmreport_datesource_urlstate
WaukeganClass II1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;United StatesUS Nationwide. Canada.99380Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC456 kitsDevicesProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.20260714Z-2943-2026Cardinal Health 200, LLC20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2943-2026IL
BestClass IIModel Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690,NetherlandsWorldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, M99378Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.4,252 unitsDevicesFirmware issue potentially leading to loss of geometry movements.20260629Z-2928-2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2928-2026
Aliso ViejoClass IICatalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)280731(10)0001224137 (01)00842429111062(11)250828(17)280731(10)0001226522 (01)00842429111062(11)250910(17)280831(10)0001264372 (01)00842429111062(11)250911(17)280831(10)0001281308 (01)00842429111062(11)250917(17)280831(10)0001283704 Lot Numbers: 0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704 United StatesWorldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.98909BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.5500 devicesDevicesDue to an increase rate of balloon pinhole defects.20260430Z-2912-2026MICROVENTION INC.20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2912-2026CA
WilmingtonClass ILot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.United StatesDistributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.98777Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.TBDDevicesManufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.20260706Z-2873-2026Spectra Medical Devices, Llc20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2873-2026MA
NorthfieldClass IIUDI-DI (each) 00193489015242, UDI-DI (case) 20193489015246, Lot Numbers: All lots produced between 05/27/2025 and 04/10/2026United StatesUS Nationwide distribution in the states and territories of Guam, Puerto Rico.99432Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG431,728DevicesMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.20260630Z-2926-2026Medline Industries, LP20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2926-2026IL
WaukeganClass II1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case)United StatesUS Nationwide. Canada.99380Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog87182 kitsDevicesProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.20260714Z-2945-2026Cardinal Health 200, LLC20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2945-2026IL
FlagstaffClass IIIncorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061,United StatesU.S. Nationwide distribution in the states of GA and RI.99143GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.13 unitsDevices10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).20260522Z-2914-2026W L Gore & Associates, Inc.20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2914-2026AZ
GarlandClass IIUDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232 G22292233 G22292234 G22292235 G22292236 G22292237 G22320238 G22320239 G22320240 G22320241 G22320242 G22320243 G22320244 G22354191 G22362192 G22362194 G22362195 R23083454 G23076104 G23076105 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111United StatesUS Nationwide distribution in the state of MN.99369Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock114,260 kitsDevicesBlack depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.20260626Z-2917-2026Galt Medical Corporation20260819https://api.fda.gov/device/enforcement.json?search=recall_number:Z-2917-2026TX
Category:

Use the device-enforcement bulk export as a structured reference for recall analysis and reproducible data processing. The package retains the relationship between the captured records, their official source export and the edition you download.

What this download contains

Recall enforcement records should not be confused with adverse-event reports or device approvals. The upstream publication date can precede the packaging date, and source classifications must retain their original context. A new package timestamp is not evidence of new recall events.

Working with this edition

Inspect the schema, source dates and sample before loading the full dataset. Use official report references when investigating individual records, and keep analytical summaries separate from medical recommendations or product safety decisions.

Product questions

Is this the same as device adverse-event data?

No. Device recall enforcement and adverse-event reports are separate source collections.

Are the records independently validated by Zentra Foundry?

The package includes its documented integrity and processing checks. That is not independent validation of every upstream event or medical conclusion.

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