Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brand
- Ethicon
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ethicon
- Product type
- Surgical Device
- Model numbers
- SXPP2B400-11
- Sizes
- 14x14 in (36x36 cm)
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 15, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for barb non-engagement.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ETHICON, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
STRATAFIX Spiral PDS Plus is a knotless tissue control device used in surgical procedures to secure tissue during closures. It is designed for bi-directional use with a spiral configuration.
Why This Is Dangerous
Barbs on the device may fail to engage tissue as intended, potentially compromising tissue closure and wound integrity.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
The recall creates a safety concern for surgical procedures using this device. Hospitals and surgeons must verify device status and may need to switch to alternatives to ensure proper tissue closure.
Practical Guidance
How to identify if yours is affected
- Verify model SXPP2B400-11
- Confirm device size 14x14 in (36x36 cm)
Where to find product info
Recall notices from Ethicon and FDA enforcement pages. Manufacturer recall communications should list steps for confirmation and return.
What timeline to expect
Refund or replacement processing commonly falls within 4-8 weeks after verification of eligibility.
If the manufacturer is unresponsive
- Contact FDA CDRH recall process for escalation
- Escalate within hospital supply chain or surgical procurement contact
How to prevent similar issues
- Rigorous procurement controls to verify device codes before use
- Subscribe to recall alerts from Ethicon and FDA
- Maintain an auditable inventory of device lot numbers and product codes
Documentation advice
Keep copies of the recall notice, device packaging, serial/lot numbers, and all correspondence with the manufacturer or healthcare facility.
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Product Details
Product Code: SXPP2B400-11; GTIN: 10705031464568; Size: 14 x 14 inches (36 x 36 cm); Sold worldwide through healthcare providers; No price listed; Availability and dates of sale not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code SXPP2B400-11
- Size 14 x 14 in (36 x 36 cm)
- Distributed worldwide through healthcare providers
- Hazard: barb non-engagement
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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