Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
5 x 93 US Probe Cover CMS-6049 Recalled by Custom Medical Specialties, Inc. Due to No endotoxin (LAL) testing to proper level.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Custom Medical Specialties, Inc. directly.
Affected Products
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Quantity: 2,610
Why Was This Recalled?
No endotoxin (LAL) testing to proper level.
Where Was This Sold?
This product was distributed to 9 states: CT, FL, IL, NJ, NY, PA, TN, VA, WI
About Custom Medical Specialties, Inc.
Custom Medical Specialties, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report