Z-1030-2022Class II

Restrata, Part Number RWM1-2X2

Name: Z-1030-2022 Restrata, Part Number RWM1-2X2
Creator: Acera Surgical Inc
Published: 2022-03-21
License: https://open.fda.gov/license/

Acera Surgical, Inc. C/O Linda Braddon, PhD / initiated 2022-03-21 / Terminated / root cause: manufacturing process

FDA source

Acera Surgical Inc began a recall of Restrata, Part Number RWM1-2X2 on 2022-03-21. FDA classified it as Class II and gives the reason as "Misprinted expiration date on the shelf-box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1030-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Posted: 2022-05-02
Terminated: 2024-08-20
Recalling firm: Acera Surgical, Inc. C/O Linda Braddon, PhD
Product: Restrata, Part Number RWM1-2X2
Product code: FRO Dressing, Wound, Drug
Reason for recall: Misprinted expiration date on the shelf-box
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated the recall by letter, either hand delivered or via certified mail, beginning on 03/21/2022. The notice explained the problem and requested return of the product.
Quantity in commerce: 83 units
Distribution: Nationwide
Product codes and lots: Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1030-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-05-02

Product code FRO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)