Browse Device Recalls
395 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 395 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 395 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 9, 2026 | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Dec 22, 2025 | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 13, 2025 | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun... | Class II | Abbott Laboratories |
| Oct 6, 2025 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Oct 6, 2025 | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Sep 18, 2025 | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... | Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... | Class II | Abbott Laboratories |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Aug 21, 2025 | i-STAT EG7+ cartridge. List Number: 03P76-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | i-STAT EG6+ cartridge. List Number: 03P77-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Apr 28, 2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
| Apr 28, 2025 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST... | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50B... | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS... | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. | transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Mar 20, 2025 | The Alinity m System is designed to automate the steps for nucleic acid testi... | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... | Class II | Abbott Molecular, Inc. |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 17, 2025 | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 17, 2025 | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-... | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 4, 2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod... | The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Mar 4, 2025 | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:... | The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Mar 4, 2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod... | the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... | Class II | Abbott Diagnostics Scarborough, 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.