CLASS II ONGOING Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use recalled
Thread Counsel is recalling LOM Disposable Surgical Gowns/Medical Gowns, Single-Use, distributed in New York. The recall was initiated on 17 Sep 2020 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-0296-2021
- FDA event ID
- 86431
- Recalling firm
- Thread Counsel, New York, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2020
- FDA classified
- 25 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 17 Sep 2020 | Recall initiated by company | |
| 25 Oct 2020 | Classified by FDA | +38 days |
| 4 Nov 2020 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Where it was distributed
Distributed to accounts in New York
Questions about this recall
Why was it recalled?
Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
Which lots are affected?
Lots 1 -47
Where was it sold?
Distributed to accounts in New York
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 26 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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