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Exact Medical Manufacturing, Inc. FDA Recalls
18 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Hays Ultrasound kit Item ID: H1000SEClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NAClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443NClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980NClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HLClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002NClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058NClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322NClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NAClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360Class IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NAClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |
| Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NAClass IIApr 29, 2021No 510k for the product to be used in a natural or surgical |