Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2022 | Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box | The mask cuff may disconnect from the device's breathing tube. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... | Product was improperly store which may cause a delay in results. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... | The product was stored incorrectly due to improper storage controls which may lead to delayed res... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2022 | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 25, 2022 | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... | The product was incorrectly shipped at room temperature rather than refrigerated. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 29, 2021 | MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes | Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 15, 2021 | CURAD REUSABLE GEL HOT/COLD PACK | The product contains natural rubber latex but the label states that it does not. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Michels Transport Medium, 20ML Prefilled Cont | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Premier Rotaclone, Rx only | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 30, 2021 | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 | Affected product was shipped from the warehouse at room temperature instead of the required refri... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 22, 2021 | ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrige... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.