Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configur... | Class II | Horiba Instruments Incorporated |
| Oct 30, 2018 | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A... | Potential for chemical analyzer to report abnormal results due to an interference with triglyce... | Class II | Horiba Instruments Incorporated |
| Feb 19, 2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are di... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Feb 19, 2016 | Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discr... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay ... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantit... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for t... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay fo... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantit... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Nov 19, 2014 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower... | HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 ... | Class II | Horiba Instruments 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.