MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-1089-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II

Product Classification:

Class II

Date Initiated: November 17, 2022

Date Posted: February 15, 2023

Recall Number: Z-1089-2023

Event ID: 91386

Reason for Recall:

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Status: Ongoing

Product Quantity: 194 cases (508 units)

Code Information:

a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 10193489205527, Lot Number: 22JDA531,22IDB178,22IDA705; b. OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/GTIN: 10193489901184, Lot Number: 22JBS296; c. VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/GTIN: 10193489735369, Lot Number: 22KBB429,22IBE503; d. DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/GTIN: 10193489457896, Lot Number: 22JMC869,22JMC852,22HMD762; e. MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/GTIN: 10193489814156, Lot Number: 22IDC043; f. GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/GTIN: 10193489214147, Lot Number: 22JDA984;

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated