Browse Device Recalls
27 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 27 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 27 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2021 | ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LANCETS 28G 100CT Item Number:2975670 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | VAPORIZER VICKS 1.5GAL Item Number: 2354942 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Apr 20, 2020 | Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product ... | Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... | Class II | Cardinal Health Inc. |
| Apr 20, 2020 | B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is... | Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... | Class II | Cardinal Health Inc. |
| Apr 20, 2020 | Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere P... | Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 16, 2018 | Presource Kit Total Joint Pack containing a double-wrapped basin component. ... | The double wrapping of this custom kit basin set is not supported by the current sterility assura... | Class II | Cardinal Health 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.