McKesson Lap Sponges Recalled for Failed Sterilization Indicator
Cypress Medical Products is recalling one case of McKesson Lap Sponges due to a failed sterilization indicator that did not change from red to blue, compromising verification of proper sterilization.
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: FDA Class II medical device recall involving failure of a critical sterilization verification mechanism. The hazard is real—surgical equipment without confirmed sterilization could lead to infection or other serious complications during clinical use. However, no illnesses or injuries have been reported, placing this at Score 3 per the rubric.
Plain-English summary
Cypress Medical Products LLC is recalling one case of McKesson Lap Sponges, X-Ray Detectable (12" x 12", 5-pack, Sterile, Part #16-2112121), due to a failure of the ethylene oxide (EO) sterilization indicator.
The sterilization indicator is designed to change color from red to blue to confirm that the product has been properly sterilized. In the affected case (Lot CJJ12-07), these indicators failed to change color, preventing users from visually confirming that sterilization was successful.
If you have received or used product from this lot, cease use immediately. Contact Cypress Medical Products LLC or your supplier for instructions regarding return or replacement of the affected product.
The recalled product
- Product
- McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
- Manufacturer
- Cypress Medical Products LLC
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 number: CJJ12-07
Distribution
Distributed in 1 state:
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