Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 30, 2025 | Material Processing Laser Products | Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3) | Class II | SHENZHEN ATOMSTACK TECHNOLOGIES |
| Sep 30, 2025 | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-0... | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139... | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | BD Pyxis Pro MedStation Main, REF: 1155-00 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesl... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with... | Incorrect titanium screw, packaged with dental implant. | Class II | Prismatik Dentalcraft, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siem... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Potential for a weak seal in some units resulting in compromise in sterility. | Class II | Alcon Research LLC |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 29, 2025 | Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray... | Over time some systems may experience loss of imaging functionality and/or poor image quality due... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿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 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿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 Gluteal Implant Product Name: Gluteal Implant Model/Catalo... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium He... | 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 Collection Tube Extender, Model 09 1004 | 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 Pectoral Implant Product Name: Pectoral Implant Model/Cata... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | CODMAN Disposable Perforator 9mm. 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 | 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 |
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.