Medtronic Clip Gun Magazines Recalled for Packaging Sterility Defect
Medtronic Neurosurgery is recalling Clip Gun Magazines because the packaging sterile barrier may be compromised without visible signs.
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: The recall involves a risk-of-harm product (sterile medical device) where a packaging defect could compromise sterility, but no injuries or illnesses have been reported.
Plain-English summary
Medtronic Neurosurgery is recalling 2,616 units of Medtronic Clip Gun Magazines (REF CM8902). The recall involves specific lot numbers: 54984, 57188, 59558, 66312, and 67988. The devices are sterile, single-use, and distributed in boxes containing five individually pouched magazines.
The recall was initiated because the packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. Although the Instructions for Use state "Do not use if package has been previously opened or damaged," the source text notes that a seal breach may go undetected by the user's naked eye.
The affected products were distributed domestically in 37 states and the District of Columbia, as well as internationally in Australia, Germany, Kenya, the Russian Federation, and South Africa. Users should check their inventory for the specific lot numbers listed and contact Medtronic Neurosurgery for further instructions.
The recalled product
- Product
- Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
- Manufacturer
- Medtronic Neurosurgery
- Affected units
- 2,616
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 (4)
- 57188
- 59558
- 66312
- and 67988
Distribution
Related recalls
Same manufacturer · Medtronic Neurosurgery
See all →- HighMedtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29
- SevereExacta External Drainage System Stopcocks May Leak or Crack
FDA (Devices) · 2024-12-25
- SevereMedtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
FDA (Devices) · 2024-12-25
- SevereMedtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateMedtronic Recalls Clip Gun Scalp Clip Kits Due to Packaging Defects
FDA (Devices) · 2018-02-21
- HighMedline Neuro IR Surgical Kit Recalled Due to Weak Seals
FDA (Devices) · 2024-07-10
- HighWindstone Medical Packaging Recalls Plastic Surgery Packs Due to Sterility Concerns
FDA (Devices) · 2017-03-08
- ModerateMEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals
FDA (Devices) · 2023-10-25
- HighMedline Circumcision Kits Recalled Due to Defective Syringes
FDA (Devices) · 2024-09-04
- HighMedline Centurion Manual Surgical Kits Recalled for Weak Seal Risk
FDA (Devices) · 2024-04-10