VICRYL Sutures recalled due to packaging defect compromising sterility
Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is real—compromised sterility in surgical sutures could cause infection—but is currently theoretical. Per the rubric, risk-of-harm medical devices without reported harm score at 3 (High).
Plain-English summary
Ethicon, Inc. is recalling VICRYL (polyglactin 910) sutures, surgical devices indicated for use in general soft tissue approximation and ligation, including ophthalmic surgery. The recall affects 341,532 units distributed worldwide, including throughout the United States and Puerto Rico.
The recall was initiated because a packaging machine defect resulted in holes in the primary packaging of affected units. This defect compromises the sterility of the product, which is critical for surgical sutures.
A compromised sterile barrier could result in infection if the affected sutures are used in surgical procedures. Healthcare facilities and surgical teams should immediately discontinue use of the affected product codes and lot numbers and quarantine remaining inventory. Affected product codes and lot numbers are detailed in the FDA recall notice.
The recalled product
- Product
- VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
- Manufacturer
- Ethicon, Inc.
- Affected units
- 341,532
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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