Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89956

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microtek Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

TMJ Arthroscopy Drape, 85''x 96''

Z-1071-2022
Recall number
Z-1071-2022
Initiated
April 08, 2022
Classification
Class II
Status
Terminated
Recalling firm
Microtek Medical Inc.
Quantity
12 cases (120 drapes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Latex content in product was labeled incorrectly as latex free.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Latex content in product was labeled incorrectly as latex free.

Code information

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

Distribution pattern

Distributed nationwide to CO, PA, and WI.