FDA Medical devices recall ·

Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK… recall

Recall number
Z-1600-2025
Date
(initiated March 3, 2025)
Company / brand
Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
4094 units
Hazard tags
Sterility
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 7) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 8) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 9) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 10) FACE PACK, Model Number: DYNJ37316D; 11) PLASTIC PACK-LF, Model Number: DYNJ57440D; 12) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 13) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 14) SATELLITE MINOR PLASTIC PACK, Model Number: DYNJ63696; 15) FACIAL/EYE PACK, Model Number: DYNJ68328; 16) BREAST PACK, Model Number: DYNJ63753; 17) BREAST PACK, Model Number: DYNJ63753; 18) TUMMY PACK, Model Number: DYNJ64886A; 19) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 20) PLASTIC BREAST PACK, Model Number: DYNJ40620F; 21) PLASTIC ENT PACK, Model Number: DYNJ64712B; 22) PLASTIC SURGERY SERV-DR GARAZO, Model Number: DYNJ34199A; 23) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 24) OCULAR PLASTICS, Model Number: DYNJ55985D; 25) TUMMY PACK, Model Number: DYNJ64886A; 26) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 27) ZURI BREAST PACK, Model Number: DYNJ67772A; 28) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 29) TUMMY PACK, Model Number: DYNJ64886A; 30) OCCULAR PLASTIC PACK, Model Number: DYNJ35741D; 31) FACELIFT PACK, Model Number: DYNJ38907; 32) BREAST PACK, Model Number: DYNJ67882; 33) KDOP PLASTIC PACK, Model Number: DYNJ37142D

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

1) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24IBH633; 2) DYNJ65109, UDI-DI: 10193489243826(each), 40193489243827(case), Lot Number: 24IBH739; 3) DYNJ34160D, UDI-DI: 10889942213542(each), 40889942213543(case), Lot Number: 24IBH802; 4) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24IBL195; 5) DYNJ66056, UDI-DI: 10193489318128(each), 40193489318129(case), Lot Number: 24IBR304; 6) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24JBL025; 7) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBM075; 8) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM318; 9) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM914; 10) DYNJ37316D, UDI-DI: 10193489672763(each), 40193489672764(case), Lot Number: 24JBT528; 11) DYNJ57440D, UDI-DI: 10193489238655(each), 40193489238656(case), Lot Number: 24JBT877; 12) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24JBV138; 13) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBV645; 14) DYNJ63696, UDI-DI: 10193489754704(each), 40193489754705(case), Lot Number: 24JBV846; 15) DYNJ68328, UDI-DI: 10193489823554(each), 40193489823555(case), Lot Number: 24JBW152; 16) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBW480; 17) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Numbe

Distribution

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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1600-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.