Olympus Cystoscopy Products Recall: Adhesive Fragments Risk Urethral Injury
Olympus recalls cystoscopy working inserts and bridges with adhesive fragments that may cause urethral injury during procedures. Affected products include A20975A (Lots 13ZW-172W) and A20976A (Lots 146W-172W).
Use caution until it’s fixed
Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. The manufacturer, Olympus Winter & lbe GmbH ("OWi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. The adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient
Contact the company
What happened, in plain English
Olympus is recalling certain cystoscopy working inserts and bridges due to adhesive fragments that can detach during use. These fragments may enter the bladder, urethra, or uterus, requiring removal and potentially extending procedures or causing additional surgery. Read more at govinfonow.com/recall/73133-olympus-cystoscopy-products-recall-adhesive-fragments-risk-urethral-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/73133-olympus-cystoscopy-products-recall-adhesive-fragments-risk-urethral-injury · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0696-2018
Cite this page
“Olympus Cystoscopy Products Recall: Adhesive Fragments Risk Urethral Injury.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73133-olympus-cystoscopy-products-recall-adhesive-fragments-risk-urethral-injury. Based on FDA recall #Z-0696-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2018%22&limit=1).
Why it’s dangerous
The new adhesive used in these products is less durable than previous versions and can detach during insertion. Fragments may fall into the bladder, urethra, or uterus, requiring retrieval and potentially causing longer procedures or additional surgery.
Who’s affected
Urology patients using the recalled cystoscopy products for procedures are most at risk. Healthcare providers who use these products for endoscopic treatments may also be affected.
How to tell if you have this one
Check for product model numbers A20975A (Lots 13ZW to 172W) or A20976A (Lots 146W to 172W) on the packaging. These are cystoscopy tools used for urological procedures.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Product Model
Identify if your cystoscopy product is A20975A (Lots 13ZW to 172W) or A20976A (Lots 146W to 172W) by checking the model number and lot number on the packaging.
Contact Olympus
Reach out to Olympus Corporation of the Americas for guidance on next steps if you have the recalled products.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0696-2018 (August 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0696-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.