TMJ Arthroscopy Drape incorrectly labeled latex-free when containing latex
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves mislabeling of a product containing latex, a common allergen. Although no illnesses or injuries have been reported, the potential for serious allergic reactions in patients and healthcare workers with latex sensitivities meets the High severity criterion for allergen mislabeling.
Plain-English summary
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes (85" x 96") because the product contains latex but was labeled as latex-free. The mislabeling creates a risk of allergic reactions for patients and healthcare workers with latex sensitivities.
The recall affects 12 cases containing 120 drapes. Affected lot numbers are: D181232 (exp. 05/01/2022), D181982 (exp. 07/01/2022), D202232 (exp. 08/01/2024), D210742 (exp. 03/01/2025), D211372 (exp. 05/01/2025), D212562 (exp. 09/01/2025), D213122 (exp. 11/01/2025), and D213402 (exp. 12/01/2025). SKU 3601, UDI 50748426008556.
The drapes were distributed nationwide to Colorado, Pennsylvania, and Wisconsin. No allergic reactions or injuries have been reported.
The recalled product
- Product
- TMJ Arthroscopy Drape, 85''x 96''
- Manufacturer
- Microtek Medical Inc.
- Category
- Medical Device — Surgical Drape
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
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