Hollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
Hollister is recalling specific lots of Onli hydrophilic urethral intermittent catheters because a manufacturing defect may cause a protrusion that leads to genitourinary trauma or bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (genitourinary trauma or bleeding) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hollister is recalling select lots of Onli 17cm Hydrophilic Urethral Intermittent Catheters. The recall involves 2,526,120 units distributed nationwide in the United States. The affected products include various sizes and configurations, such as 17cm and 40cm lengths, with specific SKU/REF numbers and lot numbers listed in the official recall notice.
The recall was initiated because Hollister identified that the affected catheters may exhibit a protrusion caused by a manufacturing defect. This defect might lead to genitourinary trauma or bleeding in patients using the devices.
Consumers and healthcare providers should stop using the affected lots immediately and contact Hollister for instructions on how to return the products or obtain replacements. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Hollister Ulc
- Affected units
- 2,526,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 5K183
- 5K193
- 5K213
- 6A253
- 6A263
- 6B053. SKU/REF 82141
Distribution
Distributed nationwide across the United States.
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