Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 20, 2020 | FlipCutter III Drill | There is potential for the blister tray to be cracked causing the sterile barrier to be compromis... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| Jan 14, 2020 | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used ... | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... | Class II | Medtronic CoreValve LLC |
| Jan 14, 2020 | Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p... | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... | Class II | Medtronic CoreValve LLC |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 2XLARGE, Gown. Item Code 9578 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK XLARGE, Gown. Item Code 9548 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK LARGE, Gown. Item Code 9518 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, 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.