CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report
Restrata, Part Number RWM1-2X2 recalled by Acera Surgical
Acera Surgical is recalling Restrata, Part Number RWM1-2X2, distributed nationwide in the US. The recall was initiated on 21 Mar 2022 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-1030-2022
- FDA event ID
- 89919
- Recalling firm
- Acera Surgical, Woodstock, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2022
- FDA classified
- 2 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Mar 2022 | Recall initiated by company | |
| 2 May 2022 | Classified by FDA | +42 days |
| 11 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Misprinted expiration date on the shelf-box
Product as listed by the FDA
Restrata, Part Number RWM1-2X2
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Misprinted expiration date on the shelf-box
Which lots are affected?
Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068
Where was it sold?
Nationwide
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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