CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Medline procedure kits labeled as recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as: Csmc/Abdominal Hyst Pack-lf, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A

Quantity recalled268 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1449-2025
FDA event ID: 96374
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2025
FDA classified: 25 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

11 Feb 2025	Recall initiated by company
25 Mar 2025	Classified by FDA	+42 days
2 Apr 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Is Medline procedure kits labeled as: Csmc/Abdominal Hyst Pack-lf, Pack Number recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure kits labeled as: Csmc/Abdominal Hyst Pack-lf, Pack Number on 11 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1449-2025.

Why was it recalled?

Which lots are affected?

1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

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Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

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