TMJ Arthroscopy Drape, 85''x 96'' recallZ-1071-2022 · Microtek Medical Inc. · initiated Apr 8, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microtek Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Latex content in product was labeled incorrectly as latex free.
FDA root cause category: Under Investigation by firm
What the company is doing
All consignees were contacted on 04/08/2022 via email. Consignees should read the recall instruction, examine their inventory, and quarantine the lots listed in the letter. The consignees should also complete the enclosed response form and email it to [email protected]. If the consignee has further distributed the product, they should identify and notify their customers of the recall.
Recall details
- Recall number
- Z-1071-2022
- Status
- Terminated
- Initiated by the company
- Apr 8, 2022
- Recalling firm
- Microtek Medical Inc.
- Quantity
- 12 cases (120 drapes)
- Product code
- PUI
- Distribution
- Distributed nationwide to CO, PA, and WI.
Product description
TMJ Arthroscopy Drape, 85''x 96''
Code information (models, lots, serial numbers)
SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MICROTEK 1Microtek Medical LLC · Drape, surgical1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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