EXP Recalls Unregistered Surgical Routers for Crani-A Procedures
EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.
What this means for you
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 but is driven by regulatory and documentation failures (lack of registration and quality system) rather than a specific physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling four units of the 2.15MMX22MM Fluted Spiral Router for CRANI-A. The product is a sterile, single-use surgical bur distributed in Tyvek/Mylar pouches. The OEM catalog number is A-CRN-S, and the original manufacturer is Anspach.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems. The agency has classified this recall as Class II.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare facilities should stop using the product and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 4
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)
- OEM Catalog number A-CRN-S.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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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