Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 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 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2025 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... | Although the etched length on the screw is correct, the length marked on the external packaging i... | Class II | Synthes (USA) Products LLC |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Carescape B450, Model no. 5805686 - shipped with potentially affected batteri... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numb... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monito... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Impl... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502 | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... | Class II | Zimmer, Inc. |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparin... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... | Although the etched length on the screw is correct, the length marked on the external packaging i... | Class II | Synthes (USA) Products LLC |
| Sep 26, 2025 | Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (Wit... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Nu... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model... | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening ... | Class II | Medistim Asa |
| Sep 26, 2025 | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... | Class II | Zimmer, Inc. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Numb... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fl... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings ... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diamet... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 25, 2025 | Artegraft¿ Collagen Vascular Graft; REF: AG1015; | The device was incorrectly packed in the wrong size labeled outer packaging. | Class II | LeMaitre Vascular, Inc. |
| Sep 25, 2025 | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression... | Class II | DJO, LLC |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... | Due to an identified manufacturing defect involving coating material lifting within the catheter'... | Class I | BALT USA, LLC |
| Sep 25, 2025 | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 24, 2025 | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F,... | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting i... | Class II | Stryker Sustainability Solutions |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 23, 2025 | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Aut... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
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.