FDAMarch 24, 2022device
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].
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
What to do
FDA enforcement status: Ongoing
Brands named
ethicon
UPCs
1070503122805410705031228047
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC802025-09-11
- FDASTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.2025-08-15
- FDAEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR352025-04-22
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP2025-03-07
- FDAPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.2024-12-20
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