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.
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 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.
See all 42 products in this recall →Related recalls
Same manufacturer · EXP Pharmaceutical Services Corp
See all →- ModerateEXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues
FDA (Devices) · 2015-08-05
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateAnspach Recalls 113 MRI Fluted Routers for Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- LowAnspach Effort Recalls Rotating Adult Craniotomes Due to Missing Service Interval
FDA (Devices) · 2017-05-10
- ModerateAnspach Recalls 130 MRI Fluted Balls Due to Quality System Non-Compliance
FDA (Devices) · 2014-07-02
- SevereStryker 2.3mm Tapered Routers Recalled Due to Breakage Risk
FDA (Devices) · 2016-07-27
- ModerateAnspach Recalls Single-Use Sterile Bone Cutting Burs Due to Length Discrepancy
FDA (Devices) · 2014-02-05
- ModerateAnspach Twist Drill Recall Due to Incorrect Length Labeling
FDA (Devices) · 2014-02-05