Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Custom Convenience Kit containing recalled Medline Namic Angiographic Control... | Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to ... | Class I | Windstone Medical Packaging, Inc. |
| Apr 2, 2026 | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| 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 |
| Mar 30, 2026 | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... | 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 |
| Mar 30, 2026 | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... | Ten complaints have been received identifying issues at the time of use related to the package se... | Class II | Zimmer, Inc. |
| Mar 27, 2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is ... | Class II | Edwards Lifesciences, LLC |
| Mar 27, 2026 | AIDBAGs are first aid kits of convenience composed of individually labeled de... | Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... | Class I | North American Rescue LLC. |
| Mar 27, 2026 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010... | Includes an incorrect screw seat interface. | Class II | Straumann USA LLC |
| Mar 27, 2026 | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous... | Includes an incorrect screw seat interface. | Class II | Straumann USA LLC |
| Mar 27, 2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | X-Ray generator may malfunction resulting in the X-Ray being inoperable. | Class II | Micro-X Ltd. |
| Mar 26, 2026 | Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000... | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command M... | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | Class II | Spacelabs Healthcare, Inc. |
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.