DeRoyal Specimen Retrieval Bags Recalled for Tearing During Use
DeRoyal Industries is recalling 5,359 Medium Specimen Retrieval Bags because they may tear or come apart during laparoscopic procedures.
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: The recall involves a medical device with a structural failure (tearing/ripping) during use, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc is recalling 5,359 units of the DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003. The device is a single-use bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity. The recall covers units distributed nationwide in the United States.
The recall was initiated after the firm received reports that the specimen retrieval bags were tearing, ripping, and coming apart during use. The source text does not report any specific injuries, illnesses, or fatalities associated with these failures.
Healthcare providers and facilities should stop using the affected devices and contact DeRoyal Industries Inc for further instructions on the recall process. Consumers should not use these prescription-only devices if they have them in their possession.
The recalled product
- Product
- DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 5,359
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 (19)
- 1211QDA403
- 1301QDA402
- 1301QDA410
- 1303QDA401
- 211QDA403
- 32046564
- 32119911
- 32338381
- 32562251
- 32783812
- 32886441
- 32891051
- 32899882
- 32942609
- 33114274
- 34939294
- 35229930
- 35579999
- 35738515
Distribution
Distributed nationwide across the United States.
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