ModerateClass IITerminated

FDA Devices recall · Reported June 6, 2018

Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-1942-2018.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1942-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Recall #: Z-1942-2018
Affected scope: 323,886 devices
Initiated: May 11, 2018

Compiled from official public sources by the publisher. · Updated August 2026

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Olsen Medical recalled Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument… - a moderate-severity action.

Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument… was recalled by Olsen Medical in June 6, 2018. Reason: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.. Check the official notice for the remedy. Verify recall #Z-1942-2018 with the FDA Devices before acting.

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The recall

Olsen Medical issued this moderate-severity FDA Devices recall-Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised..

Moderate
severity level: 324K units
affected scope: Class II
classification: June 6, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1942-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1942-2018) was formally reported on June 6, 2018, with the manufacturer initiating the action on May 11, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Olsen Medical is listed as the recalling firm, operating out of Louisville, KY. Federal records list the affected scope as 323,886 devices, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Distribution data in the federal record shows the product reached: Worldwide Distribution. Distribution scope 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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.

Severity

Moderate

Affected scope

323,886 devices

Related Recalls

6 from same agency

Product description

Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 Intended for use in coagulating tissue.

Reason for recall

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1942-2018
Date reported	June 6, 2018
Date initiated	May 11, 2018
Recalling firm	Olsen Medical
Firm location	Louisville, KY
Affected scope	323,886 devices
Distribution	Worldwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

323,886 devices units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1942-2018) 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.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-1942-2018.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1942-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 6, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.