Class II U.S. Food and Drug Administration

Hollister Ulc Onli 17cm Hydrophilic Urethral Intermittent Catheter recall: Hollister has identified that select lots of the catheters identified

Recall published last month

Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2998-2026
Published
September 2, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Hollister Ulc
Product type
Medical devices
Units affected
2526120 units
Distribution
Nationwide
Made in
Ireland
Lot / code info
SKU/REF 82081, UDI/DI 00610075072354, Lot Numbers: 5F273, 5F283, 5H293, 5J153, 6C313. SKU/REF 82101, UDI/DI 00610075072361, Lot Numbers: 5F283, 5G013, 5K253, 6A303. SKU/REF 82121, UDI/DI 00610075072385, Lot Numbers: 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053. SKU/REF 82141, UDI/DI 00610075072392, Lot Numbers: 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133. SKU/REF 82084, UDI/DI 00610075072408, Lot Numbers: 5E293, 5G213, 5G223, 6A223, 6A213. SKU/REF 82104, UDI/DI 00610075072415, Lot Numbers: 5E293, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293. SKU/REF 82124, UDI/DI 00610075072422, Lot Numbers: 5E303, 5F033, 5F063, 5F043, 5F053, 5J223, 5J283, 5J243, 5K143, 6A163, 6A153, 6B173, 6B183, 5F073. SKU/REF 82144, UDI/DI 00610075072439, 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, UDI/DI 00610075072446, Lot Numbers: 6A223, 6B183, 5F153, 5F163, 5F183, 5F173, 5G103, 5G143, 5G113, 5G153, 6A233, 6C253, 6C243, 6C223, 6C233, 6D303, 6D293, 6D283. SKU/REF 85124, UDI/DI 00610075097432, Lot Numbers: 5K143, 5K133, 6B193. SKU/REF 85144, UDI/DI 00610075097449, 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, UDI/DI 00610075097456, Lot Numbers: 6D303, 5K133, 6B193, 6A093, 6C283, 5L053, 5L043, 6A083, 5L193, 6A023, 5L223, 6A053, 6C293.
UPC codes
00610075072354, 00610075072361, 00610075072385, 00610075072392, 00610075072408, 00610075072415, 00610075072422, 00610075072439, 00610075072446, 00610075097432, 00610075097449, 00610075097456

Products covered by this recall

Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.

Check your product

The notice names 52 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00610075072354
  • 00610075072361
  • 00610075072385
  • 00610075072392
  • 00610075072408
  • 00610075072415
  • 00610075072422
  • 00610075072439
  • 00610075072446
  • 00610075097432
  • 00610075097449
  • 00610075097456

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 5F273
  • 5F283
  • 5H293
  • 5J153
  • 6C313. SKU
  • REF 82101
  • UDI
  • DI 00610075072361
  • 5G013
  • 5K253
  • 6A303. SKU
  • REF 82121
  • DI 00610075072385
  • 5E063
  • 5E073
  • 5E083
  • 5F193
  • 5F203
  • 5F213
  • 5F223

Model or item number

On the rating label, the box or the instruction sheet.

  • 82081
  • 82101
  • 82121
  • 82141
  • 82084
  • 82104
  • 82124
  • 82144
  • 82164
  • 85124
  • 85144
  • 85164. — SKU
  • REF 82081
  • UDI
  • DI 00610075072354
  • DI 00610075072361
  • DI 00610075072385
  • DI 00610075072392
  • DI 00610075072408
  • DI 00610075072415

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Hollister Ulc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Hollister Ulc — Foxford Road, Ballina

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hollister Ulc medical devices recalled?

Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding. Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00610075072354, 00610075072361, 00610075072385; lot code 5F273, 5F283, 5H293; model number 82081, 82101, 82121. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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