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Ongoing FDAEvent 99759 (20 days ago)

American Contract Systems BD Urinary Catheter Trays

Medical convenience kits with BD CliniClean Pericare Wipes may contain contaminated wipes causing skin irritation or infection risk.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

American Contract Systems Inc began a recall on August 10, 2026, of medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays, including Abdominal Hysterectomy, Robotic Pack, and Cardiac Heart Bundle models.

The kits contain manufacturer-recalled perineal care wipes that may be contaminated with a lubricant used during manufacturing, which may lead to localized skin effects such as irritation, erythema, or mild inflammation. The recall was added to the FDA's Enforcement Report on September 25, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

3 products

Affected if its UDI-DI and lot code are listed under that product.

  1. Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays Robotic Pack - 242561 Model No. MHRB88AO

    UDI-DI
    • 191072236531
    Lot
    • 42-8513411
    • 42-8580011
    • 42-8663211
    • 42-8775711
    • 42-8801311
    • 42-8840611
    • 42-8865911
  2. Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays Cardiac Heart Bundle NS Model No. LMCH99P Open Heart 2 RCH¿ 0248495 Model No. RCOH62C

    UDI-DI
    • 191072228147
    • 191072230942
    Lot
    • 42-8533511
    • 42-8669111
    • 42-8763811
    • 42-8811311
    • 42-8825411
    • 42-8869411
    • RCOH62C
    • 42-8504411
    • 42-8561511
    • 42-8668211
    • 42-8737811
    • 42-8797911
    • 42-8862511
  3. Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays Abdominal Hysterectomy - 205989 Model No. MHAH55AM Lavh-LAP Colon Model No. SPLL54U VAG HYST Pack Model No. SPVH62P

    UDI-DI
    • 191072236487
    • 191072239181
    • 191072238771
    Lot
    • 42-8529911
    • 42-8649211
    • 42-8687711
    • 42-8797811
    • 42-8857011
    • 42-8869711
    • SPLL54U
    • 07-2516111
    • 07-2528611
    • 07-2545611
    • 07-2547911
    • 07-2561411
    • SPVH62P
    • 07-2544611
    • 12-7436711

Details

Company began the recall
Sold in

US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.

Event ID
99759
Recall numbers
Z-3292-2026 to Z-3294-2026
Company
American Contract Systems IncTiffin, Ohio
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. Summary updated

  5. In FDA's weekly enforcement report

All recalls from American Contract Systems Inc

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration