Browse Device Recalls
2,601 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,601 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 2,601 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 28, 2023 | Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL,... | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after ... | Class II | MRP, LLC dba Aquabiliti |
| Dec 28, 2023 | Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit C... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm d... | Class II | NeuroLogica Corporation |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, R... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... | Class II | Maquet Medical Systems USA |
| Dec 28, 2023 | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For U... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit ... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... | Class I | Abiomed, Inc. |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | New warnings are being added to the Instructions for Use for all affected products to reduce the ... | Class II | Abiomed, Inc. |
| Dec 26, 2023 | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ... | Class II | Ossur H / F |
| Dec 26, 2023 | Senographe Pristina | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermit... | Class II | GE Medical Systems, SCS |
| Dec 26, 2023 | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
| Dec 22, 2023 | Baxter Exactamix Pro 2400, REF EXM24DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | Baxter Exactamix Pro 1200, REF EXM12DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 22, 2023 | GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ul... | GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Pr... | Class II | GE HEALTHCARE AUSTRIA GMBH & CO |
| Dec 22, 2023 | Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
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.