FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
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 is classified as FDA Class II. The hazard involves compromised sterility in a surgical setting, which presents a risk of harm (infection) even though specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 448 sterile surgical kits intended for laparoscopic cholecystectomy procedures. The kits are manufactured by Resource Optimization & Innovation LLC (ROi, LLC) of St. Louis, Missouri, and are identified by Item Number 800560 and GS0649. The specific lots affected are 16696, 19356, 21147, and 22834.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes. These defects could compromise the sterility of the surgical instruments and accessories contained within the tray. The distribution of these kits was limited to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities and consumers should stop using these kits immediately and contact the manufacturer for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 448
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 (4)
- Lot numbers 16696
- 19356
- 21147
- and 22834.
Distribution
Part of a larger recall action
This product is one of 77 recalled by Resource Optimization & Innovation Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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