Surgical Circumcision Kits Recalled Due to Non-Sterile Outer Wrapping
MEDLINE INDUSTRIES is recalling CENTURION MEDICAL PRODUCTS Circumcision Tray kits (Lot 22HMH649) because the outer packaging is non-sterile, though the surgical contents inside remain sterile.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect in the outer packaging, but the surgical contents remain sterile, making this a precautionary recall for potential contamination risk if the non-sterile outer wrapping is mishandled during storage or use.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY kits (Reorder Number CIT3345, GTIN 40653160102374) distributed nationwide. Lot 22HMH649 includes 144 units affected in this FDA Class II recall.
The recall is due to the perforated bag design not maintaining sterility of the outer wrapping. As a result, only the contents inside the kit's wrapping remain sterile, while the external packaging is not sterile.
The recalled product
- Product
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 144
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)
- Reorder Number CIT3345
- GTIN 40653160102374
- Lot # 22HMH649
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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