Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ G... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / D... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 D... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 19, 2022 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... | Class I | Datascope Corp. |
| Dec 19, 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 /... | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... | Class I | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 7, 2022 | Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Garbin Ventilator, Model Number 1058180B | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... | Class I | Covidien LP |
| Dec 5, 2022 | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ... | Class I | Cardiac Assist, Inc |
| Nov 28, 2022 | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes... | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer... | Class I | Universal Meditech Inc. |
| Nov 24, 2022 | RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used ... | Complaints of leaking packets were received. | Class I | Emergent Protective Products USA Inc |
| Oct 27, 2022 | Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheter... | There is the potential for inadequate connection between the top and bottom housings of the Micro... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 27, 2022 | Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)... | There is the potential for inadequate connection between the top and bottom housings of the Micro... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating P... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pa... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heat... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 17, 2022 | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,... | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from t... | Class I | Insulet Corporation |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL 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.