American Nitrile Operations LLC recalls Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM…
Reason for recall
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination glovesUDI-DI 81863402556282 affected lotsAO01306AO01347AO01358AO01381AO01407AO01446AO01466AO01476
+74 more
AO01500AO01513AO01535AO01536AO01551AO01631AO01584AO01634AN25051131972-RM50602818634025579AO01307AO01348AO01359AO01359AO01379AO01388AO01398AO01410AO01452AO01467AO01477AO01501AO01514AO01533AO01534AO01552AO01582AO01667AO01525AO01532AO01563AO01585AO01668AN250511396AN250511396AN25051139672-RM50603818634025555AO01304AO01313AO01364AO01378AO01387AO01395AO01399AO01405AO01411AO01424AO01432AO01444AO01453AO01454AO01468AO01469AO01479AO01480AO01504AO01515AO0163572-RM50604818634025548AO01270AO01365AO01380AO01400AO01433AO01455AO01481AO01503AO01553AN250411247AN250511398AN250511322
What the firm is doing
Firm began notifying its VA customers on August 15, 2026 via email. Instruction to Customers: 1. Immediately cease all use of the affected products. 2. Notify all users throughout your facility of the product recall. 3. Examine your inventory and immediately quarantine the affected lots to avoid accidental use 4 Contact distributor for replacement.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3289-2026
- FDA 510(k) clearance · K220825The device's official FDA premarket clearance record
- FDA device classification · LZAOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.6250The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find American Nitrile Operations LlcSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
- C-Reactive Protein Test System
- Under Investigation by firm
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the pl…
- Bone Fixation Plate
- Process control
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿
Due to incorrect inside packaging label for eyepiece.
- Nasopharyngoscope (Flexible Or Rigid)
- Employee error