MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall Details

Recall Number

Z-1617-2025

Classification

Class II

Product Type

Device

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield

Status

Ongoing

Date Initiated

03/03/2025

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3909 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Product Description

Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

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 →