FDA Device Recalls

Class IIOngoing

Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6) CRANIOTOMY, SKU CDS982719Q; 7) CRANIOTOMY, SKU CDS982719R; 8) CRANIOTOMY, SKU CDS982719S; 9) CRANIOTOMY, SKU CDS982719T; 10) CRANIOTOMY, SKU CDS982719U; 11) CRANIOTOMY, SKU CDS982719V; 12) CRANIOTOMY, SKU CDS982719W; 13) CRANIOTOMY, SKU CDS984074I; 14) SPINE, SKU CDS984943I; 15) SPINE, SKU CDS984943J; 16) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144; 17) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144A; 18) CRANIOTOMY #IMF 56646-LF, SKU DYNJVB91001; 19) NEURO SPINE #IMF 56655-LF, SKU DYNJVB91004; 20) CRANIOTOMY HARPER PACK-LF, SKU DYNJ0162022G; 21) CRANIOTOMY PACK-LF, SKU DYNJ0530906AP; 22) CRANIOTOMY PACK-LF, SKU DYNJ0530906AQ; 23) LAMINECTOMY PACK-LF, SKU DYNJ17452R; 24) LAMINECTOMY PACK-LF, SKU DYNJ17452S; 25) CRANIOTOMY PACK-LF, SKU DYNJ17455J; 26) CRANIOTOMY PACK-LF, SKU DYNJ17455K; 27) DEPAUL CRANIOTOMY-LF, SKU DYNJ20018P; 28) SPINAL PROCEDURE SC, SKU DYNJ33402K; 29) LAMINECTOMY PACK SC, SKU DYNJ35328J; 30) CRANIOTOMY PACK 9128175-LF, SKU DYNJ35982J; 31) LAMINECTOMY PACK, SKU DYNJ37683J; 32) SPINAL RECONSTRUCTION PACK, SKU DYNJ37689G; 33) CRANIOTOMY PACK, SKU DYNJ37714G; 34) CRANIOTOMY PACK, SKU DYNJ38317G; 35) SPINE PACK-LF, SKU DYNJ38889I; 36) ORTHO SPINE, SKU DYNJ40221A; 37) ORTHO SPINE, SKU DYNJ40221B; 38) ORTHO SPINE, SKU DYNJ40221C; 39) ORTHO SPINE, SKU DYNJ40221D; 40) ORTHO SPINE, SKU DYNJ40221F; 41) CRANIOTOMY PK, SKU DYNJ40388B; 42) CRANIOTOMY-LF, SKU DYNJ43319F; 43) NEURO SPINE PACK 319728, SKU DYNJ44628D; 44) CRANI PACK-LF, SKU DYNJ44805L; 45) LAMINECTOMY PACK-LF, SKU DYNJ44815J; 46) NEURO SPINE PACK, SKU DYNJ45419D; 47) NEURO SPINE PACK, SKU DYNJ45419F; 48) SPINE PACK, SKU DYNJ46317F; 49) CRANI PACK, SKU DYNJ47605B; 50) SCRIPPS SW CRANIOTOMY PACK-LF, SKU DYNJ49653C; 51) PK) NEURO-CRANI, SKU DYNJ53453A; 52) ACDF PACK-LF, SKU DYNJ57136A; 53) PEDI CRANI MAJOR, SKU DYNJ59338C; 54) UMC CRANIOTOMY, SKU DYNJ60497A; 55) UMC CRANIOTOMY PK, SKU DYNJ60497B; 56) CMC NEURO PACK-LF, SKU DYNJ61079C; 57) CMC NEURO PACK-LF, SKU DYNJ61079D; 58) CRANIOTOMY PK, SKU DYNJ65934B; 59) METREX PACK-LF, SKU DYNJ66104A; 60) CRANIOTOMY PACK, SKU DYNJ66419; 61) CRANIOTOMY PACK, SKU DYNJ66419A; 62) CRANIOTOMY PACK RFID, SKU DYNJ66419B; 63) CRANIOTOMY PACK, SKU DYNJ67355A; 64) CRANIOTOMY PACK, SKU DYNJ67355B; 65) OSC LAMINECTOMY PACK, SKU DYNJ67395; 66) SPINE PACK, SKU DYNJ67505F; 67) SPINE PACK, SKU DYNJ67505G; 68) SPINE PACK, SKU DYNJ67652A; 69) NEURO CRANI PACK, SKU DYNJ69752; 70) SPINE PACK, SKU DYNJ69753; 71) SPINE PACK, SKU DYNJ80550A; 72) CRANI PACK, SKU DYNJ80554A; 73) SPINE PACK, SKU DYNJ82105; 74) LAMINECTOMY I-LF, SKU DYNJ83783; 75) ANTERIOR CERVICAL-LF, SKU DYNJ83785; 76) NEURO-CRANI PK-LF, SKU DYNJ85475; 77) CRANIOTOMY PACK, SKU DYNJ85527A; 78) CRANIOTOMY-LF, SKU DYNJ900718D; 79) WMC ANTERIOR CERVICAL-LF, SKU DYNJ902443D; 80) WMC LAMINECTOMY-LF, SKU DYNJ902468J; 81) WMC LAMINECTOMY-LF, SKU DYNJ902468K; 82) WMC LAMINECTOMY-LF, SKU DYNJ902468L; 83) WMC LAMINECTOMY-LF, SKU DYNJ902468M; 84) WMC CRANIOTOMY ADD ON-LF, SKU DYNJ902473L; 85) CRANIOTOMY, SKU DYNJ903224R; 86) CRANIOTOMY, SKU DYNJ903224S; 87) CRANIOTOMY, SKU DYNJ903224T; 88) CRANIOTOMY, SKU DYNJ903224V; 89) DAVIS LAMI, SKU DYNJ903452D; 90) ORTHO INS-SPINE BACK, SKU DYNJ904661D; 91) ORTHO INS-SPINE ACDF, SKU DYNJ904662D; 92) CCOC SPINE EHRLER, SKU DYNJ904681F; 93) KIT) SPINE LH, SKU DYNJ906448B; 94) CRANI, SKU DYNJ906469F; 95) SPINE, SKU DYNJ907030; 96) JVL - MODULE BURR HOLE - CRAN, SKU DYNJ907147A; 97) BGMC MICRODISK-SPINAL, SKU DYNJ907349B; 98) KIT PEDI CRANI LAMI, SKU DYNJ907372A; 99) KIT SPINAL INSTRUMENTATION, SKU DYNJ907376; 100) SPINE, SKU DYNJ907819A; 101) UMC CRANIOTOMY, SKU DYNJ907945; 102)

MEDLINE INDUSTRIES, LP - Northfield

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

November 6, 2024 · DeviceView details →

Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

KIT,SPINE LH Convenience kit, SKU DYNJ906448A.

SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.

FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..

20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.

20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A