DeRoyal Recalls Surgical Kits Due to Missing Protective Tape
DeRoyal Industries is recalling 303 custom surgical kits and trays because clear protective tape was not applied during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing defect (missing tape) that could lead to exposure to patient fluids, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DeRoyal Industries Inc is recalling 303 units of custom surgical kits and trays, specifically the GEO-MED TOTAL KNEE PACK (REF 89-6664.04) and GEO-MED TOTAL HIP PACK (REF 89-6664.03). These products contain Stryker Hytrel Togas, which were recalled because the clear tape intended to prevent patient fluids from contacting the surgeon or surgical staff through the sleeve seam was not applied during the manufacturing process.
The affected products were distributed nationwide, including in South Dakota and Nebraska. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in most cases, cause temporary or medically reversible health consequences.
Healthcare facilities and consumers should stop using these specific surgical kits and trays and contact DeRoyal Industries Inc for further instructions on return or replacement.
The recalled product
- Product
- Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 303
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 (20)
- GEO-MED TOTAL KNEE PACK PGYBK
- REF 89-6664.04
- Lot numbers: 22737521
- 22924079
- 23427293
- 23536123
- 24076552
- 24435084
- 24750543
- 25088133
- 25275511
- 25598563
- 26476576
- 26924324
- 26959148
- 27264233
- 27526176
- 27756781
- 28238361
- 28481694 GEO-MED TOTAL HIP PACK
Distribution
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