Aspen Surgical Recalls Misidentified Stainless Steel Surgical Blades
Aspen Surgical Puerto Rico Corp. is recalling 6,000 stainless steel surgical blades that were incorrectly labeled as size 12 instead of 12B.
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 involves a minor labeling error (incorrect size identification) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aspen Surgical Puerto Rico Corp. is recalling 6,000 pieces of Conventional Stainless Steel Surgical Blades, catalog number 371712, lot 0088464. The product is intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
The recall was initiated after the firm received a complaint disclosing that the blades were incorrectly identified in the single unit foil pack as size 12 instead of size 12B. The agency has classified this as a Class II recall.
The affected products were distributed only in the United States. Consumers and healthcare facilities should stop using the affected blades and contact the recalling firm for further instructions.
The recalled product
- Product
- Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
- Manufacturer
- Aspen Surgical Puerto Rico Corp.
- Hazard
- Affected units
- 6,000
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 0088464
Distribution
Distribution scope not specified by the agency.
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