FDA · Class II · September 2, 2026

American Contract Systems recall: American Contract System Convenience Kit and 1 more product

American Contract Systems Inc is recalling American Contract System Convenience Kit and 1 more product – 30 units; 12 units. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on June 29, 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.
ProductAmerican Contract System Convenience Kit and 1 more product
BrandAmerican Contract Systems
CompanyAmerican Contract Systems Inc
TypeMedical devices
ClassificationClass II
Recall dateJune 29, 2026
Published by FDASeptember 2, 2026
Quantity30 units; 12 units
Recall ID99514
As listed by FDA

Recalled products (4)

  1. American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
    FDA recall number
    Z-3000-2026
    Codes, lots and dates
    Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026
    Quantity
    30 units
    Classification
    Class II
  2. American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
    FDA recall number
    Z-3001-2026
    Codes, lots and dates
    Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027
    Quantity
    30 units
    Classification
    Class II
  3. American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
    FDA recall number
    Z-3002-2026
    Codes, lots and dates
    Lot Code: Lot Number: 42-8808611 UDI: 191072241252 Expiration Date: 1/6/2027
    Quantity
    30 units
    Classification
    Class II
  4. American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
    FDA recall number
    Z-3003-2026
    Codes, lots and dates
    Lot Code: Lot Number: 70-054952 UDI: 191072219947
    Quantity
    12 units
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99514
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Tiffin, OH, United States

Why it was recalled

The reason the FDA lists: “The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications. / The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.”

Where it was sold

Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of IA, OH.”

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 99514, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other American Contract Systems recalls

DateRecallProblemAgency
Oct 7, 2026American Contract Systems recall: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary…Medical devices · 1,804 kits totalKits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter …
Serious
FDA
Class II
Aug 26, 2026American Contract Systems recall: Medical procedure kits and trays labeled as: 1) CRANI PACK and 1 more productMedical devices · 4789 kits; 160 kitsa sterility problem
Serious
FDA
Class II

All 3 American Contract Systems recalls →

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FAQ

About this recall

Is American Contract Systems American Contract System Convenience Kit recalled?

Yes. American Contract Systems Inc recalled it on June 29, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications. / The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

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.

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