Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile ...

FDA Device Recall #Z-1907-2021 — Class II — April 29, 2021

Recall Summary

Recall Number Z-1907-2021
Classification Class II — Moderate risk
Date Initiated April 29, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Exact Medical Manufacturing, Inc.
Location Lancaster, NY
Product Type Devices
Quantity 8800 units

Product Description

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Reason for Recall

No 510k for the product to be used in a natural or surgical opening to the body

Distribution Pattern

US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

Lot / Code Information

Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103

Other Recalls from Exact Medical Manufacturing, Inc.

Recall # Classification Product Date
Z-1918-2021 Class II Hays Ultrasound kit Item ID: H1000SE Apr 29, 2021
Z-1909-2021 Class II 6" x 48" Elastic Poly Probe Cover, T Tip,Tele F... Apr 29, 2021
Z-1923-2021 Class II Probe Cover, PE, Elastic Bands, 15x244cm-6"x96"... Apr 29, 2021
Z-1914-2021 Class II Probe Cover Elastic Poly 6" x 48"- Ultrasonic ... Apr 29, 2021
Z-1917-2021 Class II Probe Cover, 6" x 96", PE, w 3 elastic bands- ... Apr 29, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.