Medela Inc: Medical Device Recall in 2019 - (Recall #: Z-2061-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

Product Classification:

Class III

Date Initiated: December 5, 2018

Date Posted: July 31, 2019

Recall Number: Z-2061-2019

Event ID: 81779

Reason for Recall:

The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.

Status: Terminated

Product Quantity: 665,600 lids (6,656 cases)

Code Information:

Model Number: 90003S-100; Lot codes: 441113, 441825, 441965, 442099, 442188, 442494, 442612, 443265, 443557, 444054, 444317, 445260, 445310, 445470, 445678, 446402, 446518, 446916, 447447, 447470, 447789.

Distribution Pattern:

Nationwide distribution in IL, MO, NE, OH, RI, TN, TX, VA. International distribution in Canada Internal Medela and sales reps located in CA, CO, IL, LA, NC, NJ, NV, PA, SC, TN, TX Domestic Hospitals located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI

Voluntary or Mandated:

Voluntary: Firm initiated