DeviceSignal · Recall classified
Hollister Ulc
FDA classified a device recall on 2026-08-21 · Class II · Z-2998-2026
EventRecall classified
Effective2026-08-21
ClassificationClass II
On 2026-08-21 the FDA classified a device recall from Hollister Ulc as Class II. Product: Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17…. Recall Z-2998-2026. The firm initiated it on 2026-07-14. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2998-2026
- Classification
- Class II
- Classified on
- 2026-08-21
- Initiated on
- 2026-07-14
- Firm
- Hollister Ulc
- Reason
- 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.
- 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 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2998-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
31d84fb59f094aa7122e598e890b6da86bf90c08fdd4494fe4e1a7613e83c4f3- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)