CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Medical convenience kits recalled by American Contract Systems

American Contract Systems is recalling Medical convenience kits, distributed nationwide in the US. The recall was initiated on 4 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740; HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A; IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A; MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A; RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected

Quantity recalled32,433 total

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-0180-2026
FDA event ID: 97659
Recalling firm: American Contract Systems, Grimes, IA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Sep 2025
FDA classified: 16 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

4 Sep 2025	Recall initiated by company
16 Oct 2025	Classified by FDA	+42 days
22 Oct 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

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

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

Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

Where it was distributed

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Nationwide Iowa Illinois Minnesota South Dakota Washington

Questions about this recall

Is Medical convenience kits recalled?

Yes. American Contract Systems recalled Medical convenience kits on 4 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0180-2026.

Why was it recalled?

Which lots are affected?

ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740; HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A; IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A; MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A; RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected

Where was it sold?

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

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 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 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide