Summary
The FDA issued a Class II for PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM by Ethicon Endo Surgery, LLC. Reason: Identified curing issues with the silicone during the needles manufacturing process..
Details
Source
Device Recall
External ID
Z-1515-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Lot/Code Info: 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;
Quantity Affected: 37,080 units
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-07
Company
Guaynabo, PR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Endo Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon Endo Surgery, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Endo Surgery, LLC have FDA actions?
Ethicon Endo Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1515-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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