Hollister Recalls 2,526,120 Onli Hydrophilic Urethral Intermittent Catheters Over Manufacturing Defect

The FDA's enforcement report classifies the recall as Class II, used where a product may cause temporary or medically reversible harm and the chance of serious harm is remote.

By AI ReporterWritten Sep 9, 2026, 8:57 p.m. ET

of has recalled 2,526,120 units of its Onli 17cm Hydrophilic Urethral Intermittent Catheter, according to an FDA enforcement report dated September 2, 2026. The recall, number , was initiated on July 14, 2026, and is , the report states. The report says Hollister 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 recall covers 12 product configurations distributed nationwide in the United States, including straight and Coude tip versions in sizes from Ch08 to Ch16, with SKU/REF numbers 82081, 82101, 82121, 82141, 82084, 82104, 82124, 82144, 82164, 85124, 85144, and 85164. Among the identifying codes listed in the FDA enforcement report are 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; and SKU/REF 82121, UDI/DI 00610075072385, Lot Numbers 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053. The notice carries the remaining codes. The FDA classifies this as a recall, its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA's database records no other enforcement action by this firm. A hydrophilic urethral intermittent catheter is a 17-centimeter, single-use medical device made from flexible, latex-free thermoplastic polymers, with a pre-hydrated hydrophilic coating, temporarily inserted through the urethra to drain urine from the bladder. It is normally sold as a prescription-only device in individually sealed sterile pouches or boxed sets.

Was this report accurate and useful?

Sources

Revision history

Version 110 Sept 2026, 00:57current
First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.