Browse Device Recalls
32 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 32 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 32 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 3, 2022 | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... | Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... | Class II | Abbott Laboratories, Inc |
| Jul 12, 2021 | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... | A design defect (hardware and software) allows liquid waste pressure to build up and potentially ... | Class II | Abbott Laboratories, Inc |
| May 1, 2019 | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ... | Class II | Abbott Laboratories, Inc |
| Jan 2, 2019 | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u... | Abbott internal testing has identified that the Magnesium urine application demonstrates depresse... | Class II | Abbott Laboratories, Inc |
| Sep 7, 2018 | APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... | The firm identified customer sites where modules which the safety pacemaker label is missing. Inf... | Class II | Abbott Laboratories, Inc |
| Aug 28, 2018 | Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR... | There is a potential to generate falsely elevated serum or plasma chloride results when using the... | Class II | Abbott Laboratories, Inc |
| Jul 18, 2018 | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. | The product has a stability issue which may lead to an error code indicating "Unable to calculate... | Class II | Abbott Laboratories, Inc |
| Jul 18, 2018 | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. | The product has a stability issue which may lead to an error code indicating "Unable to calculate... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jun 14, 2018 | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Ele... | Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (M... | Class II | Abbott Laboratories, Inc. |
| May 16, 2018 | The,K -ASSAY HP assay is intended for the quantitative determination of hum... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | C3 is an in vitro diagnostic assay for the quantitative determination of C3 i... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Transferrin is an in vitro diagnostic assay for the quantitative determinatio... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | C4 is an in vitro diagnostic assay for the quantitative determination of C4 i... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Dec 8, 2017 | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Sep 29, 2017 | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 29, 2017 | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE... | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility... | Class II | Abbott Laboratories, Inc |
| Sep 9, 2015 | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit... | Incorrect tubing. | Class II | Abbott Laboratories, Inc |
| Jan 15, 2015 | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ... | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Apr 7, 2014 | Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite... | Package inserts have incorrect SmartWash parameters for Triglyceride. | Class II | Abbott Laboratories, Inc |
| Aug 12, 2013 | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th... | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ... | Class II | Abbott Laboratories, Inc |
| Dec 18, 2012 | ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali... | Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ... | Class II | Abbott Laboratories, Inc |
| Nov 16, 2012 | Clinical Chemistry Phenobarbital, list number 1E08 | Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773... | Class II | Abbott Laboratories, 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.