CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
Symmetry Olsen bipolar cord: (a) Bipolar Cord recalled by Olsen Medical
Olsen Medical is recalling Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument. The recall was initiated on 11 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1942-2018
- FDA event ID
- 80080
- Recalling firm
- Olsen Medical, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2018
- FDA classified
- 25 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 May 2018 | Recall initiated by company | |
| 25 May 2018 | Classified by FDA | +14 days |
| 6 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument recalled?
Yes. Olsen Medical recalled Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument on 11 May 2018. The recall is Class II and its status is Terminated. Recall number Z-1942-2018.
Why was it recalled?
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Which lots are affected?
all codes
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Olsen Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Symmetry Olsen bipolar forceps recalled by Olsen Medical | Olsen Medical | Sterility | KY |
| Device | CLASS II | Symmetry Olsen monopolar cord: (a) Monopolar Cord recalled | Olsen Medical | Sterility | KY |
| Device | CLASS II | Symmetry Olsen monopolar forceps recalled by Olsen Medical | Olsen Medical | Sterility | KY |
| Device | CLASS II | Symmetry Olsen Monopolar Pencil: (a) Button Switchpen recalled | Olsen Medical | Sterility | KY |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |