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
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-0176-2026
- 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
- Pacemakers & Defibrillators
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 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
Where it was distributed
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Questions about this recall
Why was it 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.
Which lots are affected?
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
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 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
17 other products · FDA event 97659This product is part of a recall event; the main page for the event is Medical convenience kits recalled by American Contract Systems.
More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |