Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach
Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.
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 potential sterility breach in a medical device used for wound care, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling specific Woundcare Replacement Kits, including models with soft, fan, and retract coax tips. These accessories are used with the Stryker InterPulse Irrigation System for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
The recall is being conducted because of a potential sterility breach in the packaging. The affected units were distributed nationwide, including in Florida, Iowa, Illinois, Indiana, Louisiana, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.
Healthcare facilities and consumers should stop using the affected kits and contact Stryker for further instructions on returns or replacements.
The recalled product
- Product
- 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Wound Care
- Hazard
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 (18)
- 0210-312-000: 12138012
- 12203012
- 12229012
- 12256012
- 12293012
- 12314012
- 12338012
- 13086012
- 13140012
- 13192012
- 0210-318-000: 14140012
- 14258012
- 0210-318-100: 12294012
- 13051012
- 0210-318-200: 12143012
- 13066012
- 14037012
- 14112012
Distribution
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