Browse Device Recalls
18 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 18 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 18 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2021 | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Co... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Tr... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Tra... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover I... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Trans... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover I... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cove... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cove... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-08... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Hays Ultrasound kit Item ID: H1000SE | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, 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.