Severity
Moderate
FDA Devices recall · Reported May 18, 2022
Latex content in product was labeled incorrectly as latex free.
Microtek Medical Inc. recalled TMJ Arthroscopy Drape, 85''x 96'' - a moderate-severity action.
TMJ Arthroscopy Drape, 85''x 96'' was recalled by Microtek Medical Inc. in May 18, 2022. Reason: Latex content in product was labeled incorrectly as latex free.. Check the official notice for the remedy. Verify recall #Z-1071-2022 with the FDA Devices before acting.
The recall
Microtek Medical Inc. issued this moderate-severity FDA Devices recall-Latex content in product was labeled incorrectly as latex free..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1071-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1071-2022) was formally reported on May 18, 2022, with the manufacturer initiating the action on April 8, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Microtek Medical Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 12 cases (120 drapes).
The documented reason for this recall is: Latex content in product was labeled incorrectly as latex free. Distribution data in the federal record shows the product reached: Distributed nationwide to CO, PA, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
12 cases (120 drapes)
Related Recalls
6
3 from same agency
TMJ Arthroscopy Drape, 85''x 96''
Latex content in product was labeled incorrectly as latex free.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1071-2022 |
| Date reported | May 18, 2022 |
| Date initiated | April 8, 2022 |
| Recalling firm | Microtek Medical Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 12 cases (120 drapes) |
| Distribution | Distributed nationwide to CO, PA, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 18, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.