Class IIOngoingZ-2605-2025
ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
Potential for barb non-engagement.
- Polydioxanone Absorbable Surgical Suture
- Under Investigation by firm
ETHICON, LLCPROct 1, 2025
Polydioxanone Absorbable Surgical Suture recalls
The FDA has posted 5 enforcement recalls of polydioxanone absorbable surgical suture devices since 2025, none of them Class I (most serious). Most recent report: Oct 1, 2025.
Class II: 5
Who is recalling these devices
Latest recalls
View all 5 in the recall browser →Class IIOngoingZ-1513-2025
Ethicon Endo Surgery, LLC recalls PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Identified curing issues with the silicone during the needles manufacturing process.
- Polydioxanone Absorbable Surgical Suture
- Process control
Ethicon Endo Surgery,…PRApr 9, 2025
Class IIOngoingZ-1515-2025
Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Identified curing issues with the silicone during the needles manufacturing process.
- Polydioxanone Absorbable Surgical Suture
- Process control
Ethicon Endo Surgery,…PRApr 9, 2025
Class IIOngoingZ-1516-2025
Ethicon Endo Surgery, LLC recalls ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Identified curing issues with the silicone during the needles manufacturing process.
- Polydioxanone Absorbable Surgical Suture
- Process control
Ethicon Endo Surgery,…PRApr 9, 2025
Class IIOngoingZ-1514-2025
Ethicon Endo Surgery, LLC recalls PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Identified curing issues with the silicone during the needles manufacturing process.
- Polydioxanone Absorbable Surgical Suture
- Process control
Ethicon Endo Surgery,…PRApr 9, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Suture, Surgical, Absorbable, Polydioxanone”). Informational only — verify against the FDA before acting.