FDA Medical Device Recalls (openFDA)
Microtek Medical Inc.: TMJ Arthroscopy Drape, 85''x 96''
- Recall number
- Z-1071-2022
- Recalling firm
- Microtek Medical Inc.
- Product
- TMJ Arthroscopy Drape, 85''x 96''
- Status
- Terminated
- Initiated
- 2022-04-08
- Posted
- not on file
- Terminated
- 2024-06-05
- Reason
- Latex content in product was labeled incorrectly as latex free.
- Root cause
- Under Investigation by firm
- Action
- 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 recall@ecolab.com. If the consignee has further distributed the product, they should identify and notify their customers of the recall.
- Quantity
- 12 cases (120 drapes)
- Distribution
- Distributed nationwide to CO, PA, and WI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PUI
- Firm FEI
- 3014342658
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28