Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect
Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.
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: This recall involves a risk-of-harm product—surgical sutures with a manufacturing defect affecting the silicone in the needle portion. Under the recall severity rubric, manufacturing defects in surgical devices that could affect performance during medical procedures constitute a High severity rating.
Plain-English summary
Ethicon Endo Surgery, LLC is recalling 37,080 units of PROLENE BLU surgical sutures due to identified curing issues with the silicone during the needles manufacturing process. The affected product is PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM.
The recalled sutures have been distributed worldwide, including to the United States and to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, and Uruguay.
The affected lot numbers are: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, and 104SER. The product codes are 8706H-15 and 8711H-16.
The recalled product
- Product
- PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Manufacturer
- Ethicon Endo Surgery, LLC
- Affected units
- 37,080
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 (15)
- Product Code: (1) 8706H-15
- (2) 8711H-16
- GMDN: 13909
- UDI-DI: (1) 10705031019430
- (2) 10705031019560
- Lot number: 104E88
- 104E89
- 1047TZ
- 104BQ0
- 104DA2
- 104JAR
- 104JPJ
- 104SES
- 104KHD
- 104SER
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ethicon Endo Surgery, LLC 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 4 products in this recall →Related recalls
Same manufacturer · Ethicon Endo Surgery, LLC
See all →- ModerateSurgical Suture Needles Recalled Due to Manufacturing Defect
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- HighEthicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect
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- HighSurgical Suture Recall Due to Silicone Curing Defect
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