EAR PACK Medical Device Recalled Over Unconfirmed Sterilization
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
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 is an FDA Class II medical device recall for unconfirmed sterilization without any reported injuries or illnesses. The hazard is theoretical—possible loss of functionality that could delay or prolong treatment—making it a High severity recall per the rubric's classification of risk-of-harm products without reported injury.
Plain-English summary
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A due to sterilization assurance concerns.
The manufacturer could not confirm that sterilization assurance requirements were met during manufacturing. If sterilization is inadequate, the device may lose functionality or fail to operate properly, potentially delaying or prolonging medical treatment.
The affected devices are identified by UDI-DI 00191072167446 with lot numbers 968241, 888241, 70-052114, 70-052727, and 70-053132. Distribution was reported in Ohio.
The recalled product
- Product
- EAR PACK , Model No SFEA12A
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device
- Affected units
- 51
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 (1)
- UDI-DI 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132
Distribution
Part of a larger recall action
This product is one of 32 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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