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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.