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.
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK
Why it was recalled
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.
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
ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380; ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A; HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464; MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A; UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335; UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A; UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A; UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number 17627819 Lot 8429011 Bag serial number 17749736; UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A; UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536 * If Bag serial number is "n/a", then all of that lot is affected
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Recall record
- Recalling firm
- American Contract Systems Inc.
- Product type
- Devices
- Recall number
- Z-0176-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Grimes, IA
- Recall initiated
- 2025-09-04
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-0176-2026 · Source: openFDA enforcement.