medical MODERATE Updated 2025-04-09

Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

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Recalled Product

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

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Hazard / Issue

Identified curing issues with the silicone during the needles manufacturing process.

Issued by

FDA

Distribution: Nationwide (United States)
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;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for PROLENE BLU 18IN(45CM) USP6-0(M0.7) →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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