CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

Medical Procedure kits and trays labeled as: Laparoscopy Pack recalled

American Contract Systems is recalling Medical Procedure kits and trays labeled as: Laparoscopy Pack, distributed in Illinois, Louisiana. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) MODEL/ITEM NUMBER EVLP61I: UDI/DI 00191072194831, Kit Lot Numbers: 12-7359211, 12-7077211 , 12-7115211, 12-7162811, 12-7224111, 42-8276811, 42-8200111; 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930, Kit Lot Numbers: 12-7288711, 12-7288711

Quantity recalled1094 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-2470-2025
FDA event ID: 97358
Recalling firm: American Contract Systems, Tiffin, OH
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jul 2025
FDA classified: 28 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

14 Jul 2025	Recall initiated by company
28 Aug 2025	Classified by FDA	+45 days
3 Sep 2025	Published in enforcement report	+6 days

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

Reason for recall

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

Where it was distributed

US distribution to states of: IL and LA

Illinois Louisiana

Questions about this recall

Why was it recalled?

Which lots are affected?

1) MODEL/ITEM NUMBER EVLP61I: UDI/DI 00191072194831, Kit Lot Numbers: 12-7359211, 12-7077211 , 12-7115211, 12-7162811, 12-7224111, 42-8276811, 42-8200111; 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930, Kit Lot Numbers: 12-7288711, 12-7288711

Where was it sold?

US distribution to states of: IL and LA

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

Other products in this recall event

8 other products · FDA event 97358

This product is part of a recall event; the main page for the event is Medical Procedure kits and trays labeled as: Anterior Hip Pack recalled.

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Anterior Hip Pack recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Born ON Arrival Kit recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Heart Pack recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Lap Chole Pack recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Cysto recalled	American Contract Systems	Sterility	IL, LA
3 Sep 2025	CLASS II	Medical Procedure kits and trays labeled as: Robot Hyst Pack recalled	American Contract Systems	Sterility	IL, LA

More recalls from American Contract Systems

All 210

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Convenience Kits, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, D & C PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
26 Aug 2026Device	CLASS II	medical procedure kits and trays labeled as: Crani Pack recalled	American Contract Systems	Sterility	IA, MN, MO

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All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide