Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Medical Convenience Kits
- Model numbers
- 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
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Medical convenience kits are used in healthcare settings for various procedures requiring sterile equipment. They are essential for ensuring patient safety during surgeries and treatments.
Why This Is Dangerous
The re-gassing of these kits after an initial sterilization failure means they have not been properly validated for safety, potentially leading to ineffective products being used in medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers face potential health risks if these medical kits are used, as their effectiveness cannot be guaranteed due to compromised sterilization processes. Immediate action is necessary to prevent harm.
Practical Guidance
How to identify if yours is affected
- Check the model number of your medical convenience kit against the affected list.
- Look for any lot numbers or bag serial numbers on the packaging.
- Discard any kits that match the recalled models.
Where to find product info
Serial numbers and lot numbers are typically found on the product packaging or insert.
What timeline to expect
Expect a timeline of 4-8 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- File a complaint with the FDA or relevant consumer safety agency.
How to prevent similar issues
- Buy medical devices from reputable manufacturers that provide clear sterilization validation.
- Check for updated recalls regularly on manufacturer's websites.
Documentation advice
Keep records of all correspondence with the manufacturer and any related receipts or product information.
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Product Details
Affected models include BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L. These products were distributed nationwide in the U.S., particularly in SD, IA, MN, WA, and IL. Sold under the brand name American Contract Systems.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Risk of compromised sterilization
- Affected models: BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L
- Sold in states: SD, IA, MN, WA, IL
- Immediate action required: stop using & contact manufacturer
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Safety Guide
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