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FDA (Device enforcement)Recalled 2022-04-08closedclass ii

Microtek Medical Inc.: TMJ Arthroscopy Drape, 85''x 96''

Is my product affected?

TMJ Arthroscopy Drape, 85''x 96''

  • UPC 50748426008556

Check against the official notice below — it lists the full affected range.

What happened

Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes measuring 85 inches by 96 inches because the product labeling incorrectly states the drapes are latex free when they actually contain latex. This mislabeling poses a risk to patients or healthcare workers with latex allergies who may use or be exposed to the product. The affected drapes were distributed nationwide to Colorado, Pennsylvania, and Wisconsin, with 12 cases (120 drapes total) involved in the recall across eight different lot codes with expiration dates ranging from May 2022 through December 2025.

The recall notice does not specify a remedy or corrective action for consumers who have obtained this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Latex content in product was labeled incorrectly as latex free.

Details from the source

Reason for recall: Latex content in product was labeled incorrectly as latex free. Distribution: Distributed nationwide to CO, PA, and WI. Quantity: 12 cases (120 drapes) Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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