Restrata Medical Device Recall: Misprinted Expiration Date on Shelf-Box Packaging
Acera Surgical Inc is recalling 83 units of the Restrata RWM1-2X2 medical device (Lot Number 51745) due to a misprinted expiration date on the shelf-box packaging distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The misprinted expiration date on the shelf-box represents a risk-of-harm product where patients or healthcare providers could use expired medical devices beyond their intended duration.
Plain-English summary
Acera Surgical Inc is recalling approximately 83 units of the Restrata medical device (Part Number RWM1-2X2, Lot Number 51745) due to a misprinted expiration date on the shelf-box label.
The shelf-box packaging displays an incorrect expiration date, which could result in use of the device beyond its actual intended expiration period. This labeling error creates a potential risk to patients or healthcare providers who may rely on the packaging date rather than verifying the correct expiration information.
The affected devices were distributed nationwide. The recalled lot is identified by Lot Number 51745 and UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068.
Healthcare providers and patients who have received this device should verify the correct expiration date with Acera Surgical Inc before use. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- Restrata, Part Number RWM1-2X2
- Manufacturer
- Acera Surgical Inc
- Category
- Medical Device
- Hazard
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068
Distribution
Distributed nationwide across the United States.
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