DeRoyal Total Hip surgical procedure kit recall due to defective components
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
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: This is an FDA Class II medical device recall affecting surgical procedure kits with defective components. Although no injuries are reported in the source document, surgical equipment where component failure could compromise sterility or functionality represents a risk of harm during patient procedures.
Plain-English summary
DeRoyal Industries Inc is recalling the KIT TOTAL HIP (reference 89-8861.07), a surgical procedure kit that contains 3M Health Care Steri Drapes which have been subject to a separate recall.
The recall affects 146 kits distributed to medical facilities across 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
Affected kits have the following lot numbers: Lot 56390773 (expiration 6/1/2026), Lot 56617464 (expiration 6/1/2026), and Lot 57085981 (expiration 10/1/2026).
Medical facilities that have received these kits should immediately cease use and contact their distributor or DeRoyal for instructions regarding return or replacement.
The recalled product
- Product
- DeRoyal KIT TOTAL HIP, REF 89-8861.07
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 146
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 (3)
- Lot Numbers: Lot 56390773 exp 6/1/2026
- Lot 56617464 exp 6/1/2026
- Lot 57085981 exp 10/1/2026
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc 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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