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 |
|---|---|---|---|---|
| Nov 11, 2020 | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance... | The radio within the device can become disassociated with the wireless access point. | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | H12+ and patient cable for the H12+ Holter Recorders with the following devic... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | S4 and patient cable for the S4 Wireless Telemeter with the following device ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | ELI PC. The ELI PC Service automatically converts resting ECG recordings coll... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabil... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | T12. Incorporates wireless electrocardiographic technology to achieve the rea... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Lead diagnostic electrocardiograph under the following device names: ELI 10, ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | X12+ and patient cable for the X12+ Telemeter with the following device name:... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
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.