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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Navigation, Inc.: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Agency Publication Date: May 9, 2014
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Affected Products

Product: BAG 9732315 MOUSE STERILE 15 PK

Lot No.: 5246110712 5316560113

Product: BIOPSY NEEDLE KIT, 9733068, PASSIVE

Lot No.: 66516213 66501413 66518413 66507713

Product: BIT 9733516 2.9mm DRILL STERILE

Lot No.: 130204G

Product: DISP 9730950 STRL SPHERE, 1 PK INSERT

Lot No.: B135276281

Product: DISP 9730951 STRL SPHERE, 5PK INSERT

Lot No.: B155300281

Product: DRAPE 9732722 TUBE STERILE O-ARM 20PK

Lot No.: D120065 D121495 D121515 D120175 D122611 D101555

Product: ENT PRGM 9734636 ADD FUSION NAV AxiEM

Lot No.: 6917614

Product: INST 9731132 KIT CR REF FRAME DRIVER 5PK

Lot No.: r683

Product: INSTRUMENT TRACKER 9733533XOM ENT 1PK

Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123

Product: KIT, 9731427, THORACIC TACTILE PROBES

Lot No.: 6688089 6095124 6095129

Product: MOUSE 9732721 STERILE O-ARM 10PK

Lot No.: 5051140611 5336060213 5162060112 4734921009

Product: PACK 9731975 TUMOR RESECTION AXIEM CR

Lot No.: 0006922410

Product: PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

Lot No.: 121130B

Product: PATIENT TRACKER 9733534XOM ENT 1PK

Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G

Product: PIN, 9733235, 100MM, STERILE, PERC REF

Lot No.: 2012110744 2013010347 2012081458

Product: PIN, 9733236, 150MM, STERILE, PERC REF

Lot No.: 2013041109

Product: SHUNT KIT 9733605 NON-INVASIVE

Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A

Product: SPHERES 8801071 1/TRAY 12PK

Lot No.: 1203122 1205291 1206251 1306081 1309101

Product: SPHERES 8801075 5/TRAY 12PK

Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121

Product: TRAJ GUIDE KIT, 9733065, BIOPSY, EXT

Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a

Product: TRAJ GUIDE KIT, 9733066, BIOPSY, INT

Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012

Product: TUMOR RES. PACK 9733553 AxiEM S.M.

Lot No.: 6402019 6402024

Product: TUMOR RESECTION KIT 9733607 NON-INVASIVE

Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C

Product: TUMOR RESECTION KIT 9733608 SKULL MOUNT

Lot No.: 120725D 130404B

Product: UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

Lot No.: 6148186

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68145
Status: Resolved
Manufacturer: Medtronic Navigation, Inc.
Manufactured In: United States
Units Affected: 25 products (26,674 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.