FDAClass II · Medical device · Recall Z-2998-2026 · Recalled September 2, 2026

Onli 17cm Hydrophilic Urethral Intermittent Catheter recall — Hollister Ulc

Agency report date: September 2, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Onli 17cm Hydrophilic Urethral Intermittent Catheter
Company / brand: Hollister Ulc
Lot / serial / date codes: 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.
Distribution: US Nationwide distribution.

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Onli 17cm Hydrophilic Urethral Intermittent Catheter recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2998-2026
Brand: All Hollister Ulc recalls
Classification: Class II
Units affected: 2526120 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Onli 17cm Hydrophilic Urethral Intermittent Catheter recall status

Companies & origin

Recalling firm location: Ballina, N/A, Ireland
Firm address: Foxford Road, REHINS, N/A

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Distribution: US Nationwide distribution.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99497
Recall initiated: July 14, 2026
FDA classified: August 21, 2026
FDA report date: September 2, 2026

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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