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Use caution Medical device recall · FDA · Published July 14, 2026

Hollister Onli Catheters May Cause Genitourinary Trauma - Recall

Hollister recalls select lots of 17cm hydrophilic urethral catheters due to manufacturing defects that may cause genitourinary trauma or bleeding. Affected units include specific SKUs and lot numbers.

🇺🇸 FDA recall #Z-2998-2026Medical deviceHollister ›
✎ GovInfoNow plain-language explainer

Hollister is recalling certain lots of Onli hydrophilic urethral catheters that may have a manufacturing defect causing a protrusion. This could lead to genitourinary trauma or bleeding if used improperly. Read more at govinfonow.com/recall/697877-hollister-onli-catheters-may-cause-genitourinary-trauma-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/697877-hollister-onli-catheters-may-cause-genitourinary-trauma-recall · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2998-2026

Cite this page

“Hollister Onli Catheters May Cause Genitourinary Trauma - Recall.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697877-hollister-onli-catheters-may-cause-genitourinary-trauma-recall. Based on FDA recall #Z-2998-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2998-2026%22&limit=1).

The FDA announced on July 14, 2026, that Hollister Ulc is recalling Onli Hydrophilic Urethral Intermittent Catheters due to a manufacturing defect that may cause genitourinary trauma or bleeding. The agency issued recall number Z-2998-2026 for the voluntary Class II recall affecting units distributed nationwide.

How to tell if you have it

  • Brand: Hollister
  • Product: Onli Hydrophilic Urethral Intermittent Catheter
  • SKU/REF 82081, Lot Numbers: 5F273, 5F283, 5H293, 5J153, 6C313
  • SKU/REF 82101, Lot Numbers: 5F283, 5G013, 5K253, 6A303
  • SKU/REF 82121, Lot Numbers: 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053
  • SKU/REF 82141, Lot Numbers: 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133
  • SKU/REF 82084, Lot Numbers: 5E293, 5G213, 5G223, 6A223, 6A213
  • SKU/REF 82104, Lot Numbers: 5E293, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293
  • SKU/REF 82124, Lot Numbers: 5E303, 5F033, 5F063, 5F043, 5F053, 5J223, 5J283, 5J243, 5K143, 6A163, 6A153, 6B173, 6B183, 5F073
  • SKU/REF 82144, Lot Numbers: 6A163, 5F113, 5F133, 5I073, 5G083, 5E243, 5E253, 5E233, 5F103, 5I123, 5F143, 5E263, 5E273, 5I113, 5E283, 5F123, 5F153, 5G093, 5G183, 5G173, 5I153, 5I133, 5I143, 5I063, 6A173, 6B243, 5I103, 6B223, 6B233, 6B253, 6B263, 6B213, 6C033, 6C043, 6B273, 6C013, 6C023, 6C053, 6B283
  • SKU/REF 82164, Lot Numbers: 6A223, 6B183, 5F153, 5F163, 5F183, 5F173, 5G103, 5G143, 5G113, 5G153, 6A233, 6C253, 6C243, 6C223, 6C233, 6D303, 6D293, 6D283
  • SKU/REF 85124, Lot Numbers: 5K143, 5K133, 6B193
  • SKU/REF 85144, Lot Numbers: 6B263, 6B273, 6C253, 5K133, 5K123, 5K113, 5K053, 5K043, 5K063, 5K073, 6A113, 6A133, 5K103, 6A123, 6A093, 6A103, 6C283, 6C263, 6C273, 6E013
  • SKU/REF 85164, Lot Numbers: 6D303, 5K133, 6B193, 6A093, 6C283, 5L053, 5L043, 6A083, 5L193, 6A023, 5L223, 6A053, 6C293

The hazard

Hollister has identified that select lots of the catheters may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding. The FDA said the hazard involves potential physical injury from the defective product.

Context

GovInfoNow's records show Hollister Ulc has issued this Class II recall for Onli Hydrophilic Urethral Intermittent Catheters on July 14, 2026. Other recent recalls of similar products include Medline Urethral Catheter Tray Recall (May 4, 2026), Medline Urethral Catheters: Surface Issues May Cause Detachment (May 4, 2026), and Medline Urethral Catheterization Tray Recall (May 4, 2026).

How to tell if you have this one

Check the SKU/REF number on the catheter label (e.g., 82081, 82101, etc.) and the lot numbers listed in the recall notice. The affected units include specific SKUs and lot numbers provided in the recall details.

  • Brand
    Hollister
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the SKU/REF number and lot numbers on your catheter to determine if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Jul 14, 202612. FDA classified it Class II: Aug 21, 202623. Published in FDA’s Enforcement Report: Sep 2, 202634. Added to GovInfoNow: Sep 8, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What specific catheters are affected by this recall?

The recall affects specific SKUs and lot numbers: 82081 (lot 5F273, 5F283, etc.), 82101 (lot 5F283, 5G013, etc.), and other SKUs with corresponding lot numbers listed in the recall notice.

Do I need to stop using these catheters immediately?

The recall does not require immediate discontinuation; however, affected units should be checked and replaced if they match the listed SKUs and lot numbers.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2998-2026 (July 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2998-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA