MEDICAL DEVICE RECALLMODERATE

Onli Hydrophilic Urethral Intermittent Catheters

Hollister recalls Onli intermittent catheters due to a protrusion defect that may cause genitourinary trauma or bleeding.

What to do

Stop using the recalled catheters and contact Hollister for instructions on returning the product and obtaining a replacement or refund.

Recalled

2026-07-14

Listed

2026-08-21

Updated

2026-08-23

Recall No.

Z-2998-2026

Agency

FDA

Firm

Hollister Ulc

Recall ID

99497

Status

ONGOING

Recall at a glance

Quantity recalled: 2526120 units

Why it was recalled

Hollister is recalling select lots of Onli hydrophilic urethral intermittent catheters because a manufacturing defect may cause a protrusion that could lead to genitourinary trauma or bleeding. The recall includes 17cm and 40cm lengths in various French sizes, including straight and coude tip variants.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeledUDI-DI: 00610075072354, 00610075072361, 00610075072385, 00610075072392, 00610075072408, 00610075072415, 00610075072422, 00610075072439, 00610075072446, 00610075097432, 00610075097449, 00610075097456

Product	Lot code
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	–
as	5F273, 5F283, 5H293, 5J153, 6C313, 5G013, 5K253, 6A303, 5H283, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053, 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133, 5E293, 5G213, 5G223, 6A223, 6A213, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293, 5F033, 5F063, 5F043, 5F053 (+88 more, see the official notice)

Product

Lot code

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

–

5F273, 5F283, 5H293, 5J153, 6C313, 5G013, 5K253, 6A303, 5H283, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053, 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133, 5E293, 5G213, 5G223, 6A223, 6A213, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293, 5F033, 5F063, 5F043, 5F053 (+88 more, see the official notice)

Where it was sold

Distributed nationwide.

Timeline

2026-07-14Firm initiated recall
2026-08-21Publicly announced
2026-08-23Listed on Recall Canary
2026-08-23Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification