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-0174-2026
- 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 BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO 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?
BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421; CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370; IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124; MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A; PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184; UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283; UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number 17598793 * 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 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 Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |