Ethicon, Inc. Us 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]. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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].
Brand
Ethicon, Inc. Us
Lot Codes / Batch Numbers
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Products Sold
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Ethicon, Inc. Us is recalling STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [3 due to Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Recommended Action
Per FDA guidance
A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026