CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report
Wallach Loop Electrode Square recalled by CooperSurgical
CooperSurgical is recalling CooperSurgical Wallach Loop Electrode Square, distributed in California, Maryland, Missouri, New Jersey, Pennsylvania, Texas. The recall was initiated on 30 Apr 2021 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-1847-2021
- FDA event ID
- 87920
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2021
- FDA classified
- 10 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 30 Apr 2021 | Recall initiated by company | |
| 10 Jun 2021 | Classified by FDA | +41 days |
| 16 Jun 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
Where it was distributed
US distribution to: CA, MD, MO, NJ, PA, and TX
Questions about this recall
Is Wallach Loop Electrode Square recalled?
Yes. CooperSurgical recalled Wallach Loop Electrode Square on 30 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1847-2021.
Why was it recalled?
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Which lots are affected?
Lot 274420
Where was it sold?
US distribution to: CA, MD, MO, NJ, PA, and TX
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.
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