FDA Devices recall · Reported March 7, 2018
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and dela…
Olympus Corporation of the Americas recalled A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way… - a moderate-severity action.
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way… was recalled by Olympus Corporation of the Americas in March 7, 2018. Reason: Olympus has received complaints about fragments of adhesive which detached from inside the working channel of…. Check the official notice for the remedy. Verify recall #Z-0696-2018 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-Olympus has received complaints about fragments of adhesive which detached from inside the working channel of….
- Moderate
- severity level
- 9K units
- affected scope
- Class II
- classification
- March 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0696-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
Reason for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0696-2018 |
| Date reported | March 7, 2018 |
| Date initiated | August 18, 2017 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 8741 |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0696-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026