Day Surgery General Pack medical kit recalled for sterilization concern
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves unconfirmed sterilization of surgical instruments due to environmental control failures, representing a risk-of-harm scenario. No illnesses or injuries have been reported, placing this at the high-risk level per the rubric.
Plain-English summary
American Contract Systems, Inc. recalled 280 units of the Day Surgery General Pack (model FHGE18T) due to sterilization assurance concerns. The company identified that humidity readings in one controlled storage environment fell outside acceptable specifications, making it impossible to confirm that the devices met sterilization requirements.
The affected product lot (2405131) was distributed nationwide to healthcare facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. These are medical convenience kits used in surgical settings.
No injuries or illnesses have been reported. Healthcare facilities that received affected units should cease using them and contact American Contract Systems or the FDA for return instructions and replacement products.
The recalled product
- Product
- Day Surgery General Pack, FHGE18T; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00191072210517
- Lot: 2405131
- Exp: 05/13/2025
Distribution
Part of a larger recall action
This product is one of 19 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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