FDA Device recall Z-0726-2025
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N by Medline Industries Northfield, citing 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 produ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0726-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-06 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
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)
Reason
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
Identifiers
| code_info | UDI-DI: CDS780045N, 10193489355406 (each), 40193489355407 (case), Lot Numbers: 22JBI816 22JBI817; UDI-DI: CDS780119U,…UDI-DI: CDS780045N, 10193489355406 (each), 40193489355407 (case), Lot Numbers: 22JBI816 22JBI817; UDI-DI: CDS780119U, 10193489371116 (each), 40193489371117 (case), Lot Numbers: 22CBL018 21KBV760 21KBV761 21IBV579 21HBB379 21CBC828 21ABJ206 20JBX601 20HBC289; UDI-DI: CDS780119V, 10195327114916 (each), 40195327114917 (case), Lot Numbers: 22FBU189 22DBN874; UDI-DI: CDS981753K, 10193489848946 (each), 40193489848947 (case), Lot Numbers: 22DLA844; UDI-DI: CDS981923X, 10195327434298 (each), 40195327434299 (case), Lot Numbers: 23HBS882; UDI-DI: CDS982719Q, 10193489634853 (each), 40193489634854 (case), Lot Numbers: 20LBD073 20KBE409 20IBD650 20IBE719 20GBT868 20EBI282; UDI-DI: CDS982719R, 10193489441031 (each), 40193489441032 (case), Lot Numbers: 22CBD762 22CBD763 21LBG182 21IBU365 21DBU895 21CBA765 21BBN538; UDI-DI: CDS982719S, 10195327148348 (each), 40195327148349 (case), Lot Numbers: 22GBX154 22GBX157 22FBN679; UDI-DI: CDS982719T, 10195327264161 (each), 40195327264162 (case), Lot Num |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2025%22
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