🔍 RecallPedia

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Class I - Dangerous
🏥 Medical Devices Recalled: May 18, 2023 MEDLINE INDUSTRIES, LP - Northfield Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;
  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:
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Product Codes/Lot Numbers:

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2177-2023

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