Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns
Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.
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 risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Ethicon Endo-Surgery, LLC is recalling the PSX PROXIMATE Skin Staple Extractor. The recall was initiated because damage to the packaging may have compromised the sterility of the device. The product is used for routine skin closure in a wide variety of surgical procedures.
The recall involves 5,894,975 pieces with expiration dates ranging from September 2012 to August 2017. The devices were distributed worldwide, including in the United States and numerous international countries. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected devices and contact Ethicon Endo-Surgery for further instructions or a return.
The recalled product
- Product
- PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- Affected units
- 5,894,975
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)
- Expiration dates: September 2012 - August 2017
Distribution
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