Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1 Recalled by Ethicon, Inc. Due to Affected product lots may contain the incorrect needle...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon, Inc. directly.
Affected Products
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Quantity: 2808 (all OUS)
Why Was This Recalled?
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Where Was This Sold?
International distribution in the country of China.
About Ethicon, Inc.
Ethicon, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report