Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q

Product Codes/Lot Numbers:

1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1449-2025

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