FDA · Class II · October 7, 2026

American Nitrile Operations recall: Performance Pro and 2 more products

American Nitrile Operations Llc is recalling Performance Pro and 2 more products – 99,724,000; 36,793,000; 17,481,000. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 14, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductPerformance Pro and 2 more products
BrandAmerican Nitrile Operations
CompanyAmerican Nitrile Operations Llc
TypeMedical devices
ClassificationClass II
Recall dateAugust 14, 2026
Published by FDAOctober 7, 2026
Quantity99,724,000; 36,793,000; 17,481,000
Recall ID99748
As listed by FDA

Recalled products (3)

  1. 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 gloves
    FDA recall number
    Z-3289-2026
    Codes, lots and dates
    Item No. 72-RM50601 UDI-DI 818634025562 Lots AO01306 AO01347 AO01358 AO01381 AO01407 AO01446 AO01466 AO01476 AO01500 AO01513 AO01535 AO01536 AO01551 AO01631 AO01584 AO01634 Alternate Lot AN250511319 Item No. 72-RM50602 UDI-DI 818634025579 Lots AO01307 AO01348 AO01359 AO01359 AO01379 AO01388 AO01398 AO01410 AO01452 AO01467 AO01477 AO01501 AO01514 AO01533 AO01534 AO01552 AO01582 AO01667 AO01525 AO01532 AO01563 AO01585 AO01668 Alternate Lots AN250511396 AN250511396 AN250511396 Item No. 72-RM50603 UDI-DI 818634025555 Lots AO01304 AO01313 AO01364 AO01378 AO01387 AO01395 AO01399 AO01405 AO01411 AO01424 AO01432 AO01444 AO01453 AO01454 AO01468 AO01469 AO01479 AO01480 AO01504 AO01515 AO01635 Item No. 72-RM50604 UDI-DI 818634025548 Lots AO01270 AO01365 AO01380 AO01400 AO01433 AO01455 AO01481 AO01503 AO01553 Alternate lots AN250411247, AN250511398, AN250511322
    Quantity
    99,724,000
    Classification
    Class II
  2. Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves
    FDA recall number
    Z-3290-2026
    Codes, lots and dates
    Item No. 72-RM50900 UDI-DI 818634025517 Lots AO01292 AO01356 AO01430 AO01457 Item No. 72-RM50901 UDI-DI 818634025449 Lots AO01357 AO01431 AO01458 Item No. 72-RM50902 UDI-DI 818634025456 Lots AO01274 AO01351 AO01355 AO01426 AO01427 AO01429 AO01448 AO01456 AO01377 AO01384 Alternate lots AN250511407, AN250211237, AN250411331, AN250211252, AN250211236, AN250211237, AN250511407 Item No. 72-RM50903 UDI-DI 818634025463 Lots AO01309 AO01346 AO01353 AO01385 AO01396 AO01425 Alternate lot AN250511332 Item No. 72-RM50904 UDI-DI 818634025470 Lots AO01310 AO01339 AO01352 AO01354 AO01386 AO01408 Alternate lots AN250511409, AN250511333
    Quantity
    36,793,000
    Classification
    Class II
  3. Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove
    FDA recall number
    Z-3291-2026
    Codes, lots and dates
    Item No. 72-RM50800 UDI-DI 818634025487 Lots AO01519 Item No. 72-RM50801 UDI-DI 818634025401 Lots AO01518 AO01564 Item No. 72-RM50802 UDI-DI 818634025418 Lots AO01517 AO01531 AO01530 AO01568 Item No. 72-RM50803 UDI-DI 818634025425 Lots AO01529 AO01567 AO01593 AO01594 Item No. 72-RM50804 UDI-DI 818634025432 Lots AO01222 AO01528 AO01566 Alternate lots AN250310948, AN250310947, AN250310945, AN250311327
    Quantity
    17,481,000
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99748
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Grove City, OH, United States

Why it was recalled

The reason the FDA lists: “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.”

Where it was sold

Nationwide. Distribution as the FDA records it: “US Nationwide distribution.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99748, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Latest

Other medical device recalls

DateRecallProblemAgency
Oct 7, 2026Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 unitsPotential cracks in the hose, which could lead to leakage or the hose falling off.
Most serious
FDA
Class I
Oct 7, 2026Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 totala fire hazard
Most serious
FDA
Class I
Oct 7, 2026Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepiecesDue to incorrect inside packaging label for eyepiece.
Serious
FDA
Class II
Oct 7, 2026Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 unitsPotential for irregular oxygen readings due to a manufacturing issue affecting certain oxy…
Serious
FDA
Class II
Oct 7, 2026Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS)The potential for falsely elevated results.
Serious
FDA
Class II
Oct 7, 2026Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof…
Serious
FDA
Class II
FAQ

About this recall

Is American Nitrile Operations Performance Pro recalled?

Yes. American Nitrile Operations Llc recalled it on August 14, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

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.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

Cookies

We measure traffic so we know which stories you care about. You can change your choice at any time.