Anewmed Corporation Recalls Various Medical Devices Due to Sterilization Data Issues
Anewmed Corporation is recalling 1,749 medical devices because the contract sterilizer lacked adequate packaging data to support the 2-year shelf life.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a lack of adequate data to support shelf life, which is a quality control and labeling issue rather than a direct, reported injury or high-risk pathogen exposure.
Plain-English summary
Anewmed Corporation is recalling 1,749 various medical devices that were contract sterilized. The recall is being conducted because the contract sterilizer did not have adequate packaging data to support the 2-year shelf life claimed for these products.
The affected devices were distributed nationwide in the states of Alabama, Colorado, Florida, Indiana, Kentucky, Mississippi, North Carolina, Ohio, South Carolina, Tennessee, and Texas. The recall covers a wide range of product numbers and lot codes, including but not limited to G26862, 8065751801, E7924, and numerous others listed in the official recall notice.
Consumers and healthcare facilities should check their inventory for the specific product numbers and lot codes listed in the FDA recall notice. If any of these devices are found, they should be removed from service and returned to Anewmed Corporation or the distributor as instructed.
The recalled product
- Product
- Various products which were contract sterilized.
- Manufacturer
- Anewmed Corporation
- Hazard
- Affected units
- 1,749
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 (20)
- Product Number (Lot Code): 1. G26862 (W3915653)
- 2. 8065751801 (15027297X-2015-06)
- 3. E7924 (HD1206703)
- 4. MCFK64 (MBKY190)
- 5. PCB502090 (16105672
- 17525844)
- 6. PCB602090 (17766962
- 17716501
- 17505067
- 17465154
- 17339717
- 17191941
- 16536005
- 15473410
- 15441264
- 16685888)
- 7. PCB702090 (16722293)
- 8. 277-10-50 (12094017)
- 9. 420024 (73B1500332)
- 10. 160636 (1202143
Distribution
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