Class II FDA device recall · Z-1600-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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 it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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 Number: 24JBX780; 18) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24JBX789; 19) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBA440; 20) DYNJ40620F, UDI-DI: 10195327631321(each), 40195327631322(case), Lot Number: 24KBB123; 21) DYNJ64712B, UDI-DI: 10198459166037(each), 40198459166038(case), Lot Number: 24KBB906; 22) DYNJ34199A, UDI-DI: 10884389380406(each), 40884389380407(case), Lot Number: 24KBC573; 23) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24KBC625; 24) DYNJ55985D, UDI-DI: 10193489288940(each), 40193489288941(case), Lot Number: 24KBC670; 25) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBC738; 26) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24KBC750; 27) DYNJ67772A, UDI-DI: 10195327209704(each), 40195327209705(case), Lot Number: 24KBC752; 28) DYNJ46737A, UDI-DI: 10889942116553(each), 40889942116554(case), Lot Number: 24KBE585; 29) DYNJ64886A, UDI-DI: 10193489916355(each), 40193489916356(case), Lot Number: 24KBF385; 30) DYNJ35741D, UDI-DI: 10889942108534(each), 40889942108535(case), Lot Number: 24KBF775; 31) DYNJ38907, UDI-DI: 10884389722176(each), 40884389722177(case), Lot Number: 24KBH241; 32) DYNJ67882, UDI-DI: 10193489449532(each), 40193489449533(case), Lot Number: 24KBH367; 33) DYNJ37142D, UDI-DI: 10195327467708(each), 40195327467709(case), Lot Number: 24KBI482

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1600-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2025-03-03

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1600-2025 · Source: openFDA enforcement.