Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutme... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 24, 2025 | Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device M... | Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... | Class II | Guangzhou Pluslife Biotech Co., Ltd. |
| Jan 24, 2025 | Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid T... | Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... | Class II | Guangzhou Pluslife Biotech Co., Ltd. |
| Jan 23, 2025 | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The B... | Due to fingerprint scanner failing resulting in the scanner heating up. | Class II | CareFusion 303, Inc. |
| Jan 23, 2025 | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pul... | The initial current in certain chargers may lead to overheating and damage to the power resistors... | Class II | LUMENIS, LTD. |
| Jan 23, 2025 | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite ... | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in th... | Class II | CareFusion 303, Inc. |
| Jan 21, 2025 | A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate,... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | LIFEPAK 35 ECG cable REF 11111-000041 | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | Class II | Physio-Control, Inc. |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left In... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2... | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methe... | Class II | Physio-Control, Inc. |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 1... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Mod... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right ... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 1... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. ... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fi... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right In... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right I... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Inten... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Int... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Jan 17, 2025 | 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plu... | Due to increase in complaints related to leak alarms | Class II | KCI USA, INC. |
| Jan 17, 2025 | Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catal... | Regulatory documentation error and misleading color packaging claim. | Class II | Zhejiang Luyao Electronics Technology Co., Ltd. |
| Jan 17, 2025 | 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US -... | Due to increase in complaints related to leak alarms | Class II | KCI USA, INC. |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sen... | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming pr... | Class II | Spectrum Medical Inc |
| Jan 16, 2025 | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeut... | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... | Class II | Scientia Vascular, Inc. |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 15, 2025 | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model... | Devices presented a condition in which the inner needle separated from the hub and produced a lon... | Class II | Hologic, Inc |
| Jan 15, 2025 | IntelliBridge EC10 Module. Model Number: 865115 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a componen... | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... | Class I | Getinge Usa Sales Inc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX500. Model Number: 866064 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
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.