Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2019 | Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649 | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 4, 2019 | Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 4, 2019 | Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 4, 2019 | Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Cathe... | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 4, 2019 | PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 4, 2019 | Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G498... | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... | Class II | Cook Inc. |
| Jan 3, 2019 | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... | There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate | Class I | ICU Medical, Inc. |
| Jan 2, 2019 | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u... | Abbott internal testing has identified that the Magnesium urine application demonstrates depresse... | Class II | Abbott Laboratories, Inc |
| Jan 2, 2019 | BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... | A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jan 2, 2019 | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope... | The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. | Class II | Leica Microsystems, 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.