Browse Device Recalls
5 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5 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 5 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 8, 2025 | The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a... | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim list... | Class II | Beckman Coulter Ireland, Inc. |
| Oct 14, 2025 | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarb... | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactat... | Class II | Beckman Coulter Ireland, Inc. |
| Apr 23, 2025 | Apo B Reagent, REF: OSR6143 | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value... | Class III | Beckman Coulter Ireland, Inc. |
| Oct 18, 2018 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... | Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... | Class II | Beckman Coulter Inc. |
| Jan 29, 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... | The device may process the same sample with two different sample IDs and sample information while... | Class II | Beckman Coulter 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.