Z-1071-2022Class II

TMJ Arthroscopy Drape, 85''x 96''

Name: Z-1071-2022 TMJ Arthroscopy Drape, 85''x 96''
Creator: Microtek Medical Inc.
Published: 2022-04-08
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2022-04-08 / Terminated / root cause: labeling and UDI

FDA source

Microtek Medical Inc. began a recall of TMJ Arthroscopy Drape, 85''x 96'' on 2022-04-08. FDA classified it as Class II and gives the reason as "Latex content in product was labeled incorrectly as latex free". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1071-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-08
Posted: 2022-05-12
Terminated: 2024-06-05
Recalling firm: Microtek Medical LLC
Product: TMJ Arthroscopy Drape, 85''x 96''
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Latex content in product was labeled incorrectly as latex free.
Root cause tag: labeling and UDI
FDA 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 [email protected]. If the consignee has further distributed the product, they should identify and notify their customers of the recall.
Quantity in commerce: 12 cases (120 drapes)
Distribution: Distributed nationwide to CO, PA, and WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-12

Product code PUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)