MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall Details

Recall Number

Z-1462-2025

Classification

Class II

Product Type

Device

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield

Status

Ongoing

Date Initiated

02/11/2025

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1228 units

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.

Product Description

Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Other Recalls by MEDLINE INDUSTRIES, LP - Northfield

• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class II: Risk 07/23/2025
  Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
• Class I: Dangerous 07/14/2025
  Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
• Class II: Risk 07/08/2025
  Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

View all recalls by MEDLINE INDUSTRIES, LP - Northfield →