Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 34,608 FDA device recalls — Class II.

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DateProductReasonClassFirm
Apr 10, 2026 BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOL... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHY... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIO... Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 10, 2026 BARD Dynamic Tip Steerable, Product Number 6DYNTP001; Incomplete seals on sterile product Class II Stryker Sustainability Solutions
Apr 9, 2026 Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... Due to nonconforming products being inadvertently distributed. Class II Stryker Corporation
Apr 8, 2026 Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Pacing Catheter, Models: D200F7; Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D... Complaints have been received of systems developing loose, missing, or broken internal bolts over... Class II Hologic, Inc
Apr 8, 2026 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... Class II Medtronic Neuromodulation
Apr 8, 2026 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, S... Complaints have been received of systems developing loose, missing, or broken internal bolts over... Class II Hologic, Inc
Apr 7, 2026 BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... Class II Becton Dickinson & Co.
Apr 7, 2026 BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... Class II Becton Dickinson & Co.
Apr 6, 2026 QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, strepto... Product has the potential for false positive results Class II Quidel Corporation
Apr 6, 2026 LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xW... Stent-assisted coiling device may due to commingling during manufacturing have dimensional noncon... Class II MICROVENTION INC.
Apr 3, 2026 TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 4... Due to incorrect functional length on device labeling. Class II Grace Medical, Inc.
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 2, 2026 One Step UTI in vitro diagnostic test REF: 3374 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step 10A in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to break... Class II Intuitive Surgical, Inc.
Apr 2, 2026 One Step pH in vitro diagnostic test REF: 31I4P The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step P in vitro diagnostic test REF: 8194 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 Uric Acid in vitro diagnostic test REF: 31H0P The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 One Step K in vitro diagnostic test REF: 81A4 The devices were distributed without required FDA premarket clearance or approval. Class II DFI Co., Ltd.
Apr 2, 2026 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY catheter may experience resistance when being advanced over the guidewire Class II Merit Medical Systems, Inc.
Apr 2, 2026 Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY catheter may experience resistance when being advanced over the guidewire Class II Merit Medical Systems, Inc.
Apr 2, 2026 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens... Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mT... Class II Siemens Healthcare Diagnostics Inc
Apr 2, 2026 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY catheter may experience resistance when being advanced over the guidewire Class II Merit Medical Systems, Inc.
Apr 1, 2026 ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated ... Class II Aniara Diagnostica LLC
Apr 1, 2026 Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 Respiratory/sore throat panel test may result in false negative results and control failures. Class II BioFire Diagnostics, LLC
Apr 1, 2026 i-STAT EG6+ cartridge; List Number: 03P77-25; Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... Class II Abbott Point Of Care Inc.
Apr 1, 2026 i-STAT EG7+ cartridge; List Number: 03P76-25; Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... Class II Abbott Point Of Care Inc.
Apr 1, 2026 i-STAT G3+ cartridge; List Number: 03P78-26; Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... Class II Abbott Point Of Care Inc.
Mar 31, 2026 Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (72222... Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 31, 2026 ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation ... Class II Erbe Medical, LLC
Mar 31, 2026 ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEF... Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation ... Class II Erbe Medical, LLC
Mar 31, 2026 ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sou... Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation ... Class II Erbe Medical, LLC
Mar 30, 2026 LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATI... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... Class II Boston Scientific Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.