PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

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 CDS98271

Reported: January 1, 2025 Initiated: November 6, 2024 #Z-0726-2025 22,970 kits units

MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on January 1, 2025. Classified as Moderate severity (Class II). Approximately 22,970 kits units are affected. The recall was issued because: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expect…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0726-2025) was formally reported on January 1, 2025, with the manufacturer initiating the action on November 6, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 22,970 kits units are affected.

The documented reason for this recall is: 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 S… Distribution data in the federal record shows the product reached: US Nationwide. Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

22,970 kits

Related Recalls

6

6 from same agency

Product Description

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 for Recall

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

Details

Units Affected
22,970 kits
Distribution
US Nationwide. Canada.
Location
Northfield, IL

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-0726-2025
Date reported January 1, 2025
Date initiated November 6, 2024
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Units affected 22,970 kits
Distribution US Nationwide. Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

22,970 kits units affected — limited or regional distribution scale.

Regional (<10K units) —
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) —
Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 22,970 kits.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0726-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0726-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

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All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).