Ethicon Recalls Stratafix Spiral Sutures Due to Testing Failures
Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the defect is described as a failure to meet internal testing specifications rather than a specific high-risk hazard.
Plain-English summary
Ethicon, Inc. is recalling 660 units of 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, model SXPP1B402. The recall was initiated because the product did not meet certain internal testing specifications.
The affected units are identified by Lot Numbers PAH073 and PAH054, with an expiration date of 12/31/2020. The GTIN for the product is 10705031236059. Distribution was international, including Australia, Hong Kong, India, Japan, Korea, Singapore, and Thailand.
Healthcare providers and facilities should stop using the affected sutures and contact Ethicon, Inc. for further instructions regarding the return or disposal of the product.
The recalled product
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 660
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 (2)
- GTIN: 10705031236059 Lot Numbers: PAH073
- PAH054 Expiration Date: 12/31/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · quality defect
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Lidocaine HCL Injection Ampules Recalled for Quality Issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- ModerateMedline Ophthalmic Pack with Lidocaine Injection Kits Recalled
FDA (Devices) · 2026-07-08