Recall archive / FDA device enforcement
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) C... — FDA record Z-0794-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) ANTERIOR CERVICAL CDS, REF CDS780205O; 11) ANTERIOR CERVICAL CDS, REF CDS780205P; 12) ANTERIOR CERVICAL CDS, REF CDS780205Q; 13) CRANIOTOMY CDS, REF CDS780206O; 14) CRANIOTOMY CDS, REF CDS780206P; 15) CRANIOTOMY CDS, REF CDS780206R; 16) NEURO-LAMI CDS, REF CDS780208I; 17) SHY CRANIOTOMY CDS, REF CDS780214M; 18) SHY CRANIOTOMY CDS, REF CDS780214N; 19) SPINAL CDS, REF CDS940087AL; 20) ORTHO SPINE PROCEDURE, REF CDS940875P; 21) CRANIOTOMY-RICHMOND, REF CDS980929Q; 22) CRANIOTOMY-RICHMOND, REF CDS980929R; 23) CRANIOTOMY-RICHMOND, REF CDS980929S; 24) CRANIOTOMY-RICHMOND, REF CDS980929T; 25) CRANIOTOMY-RICHMOND, REF CDS980929U; 26) OMC LUMBAR CDS, REF CDS981062I; 27) LAMINECTOMY CDS, REF CDS981229A; 28) ORTHO SPINE SUPPLEMENTAL CDS, REF CDS981742M; 29) CRANIOTOMY CDS, REF CDS981888X; 30) ANTERIOR CERVICAL DISC, REF CDS982023S; 31) ANTERIOR CERVICAL DISC, REF CDS982023T; 32) CRANIOTOMY, REF CDS982029R; 33) CRANIOTOMY, REF CDS982029S; 34) LAMI FUSION, REF CDS982035T; 35) LAMI FUSION, REF CDS982035U; 36) MICRODISCECTOMY, REF CDS982054W; 37) CRANIOTOMY CDS, REF CDS982480L; 38) CRANIOTOMY CDS, REF CDS982480M; 39) CRANIOTOMY CDS, REF CDS982480N; 40) CRANIOTOMY CDS, REF CDS982480O; 41) CRANIOTOMY CDS, REF CDS982480P; 42) LAMINECTOMY CDS, REF CDS982491L; 43) LAMINECTOMY CDS, REF CDS982491M; 44) LAMINECTOMY CDS, REF CDS982491N; 45) LAMINECTOMY CDS, REF CDS982491O; 46) LAMINECTOMY CDS, REF CDS982491P; 47) LAMINECTOMY CDS, REF CDS982491Q; 48) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563C; 49) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563D; 50) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563F; 51) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563G; 52) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563I; 53) NEURO SPINE CDS, REF CDS982683O; 54) NEURO SPINE CDS, REF CDS982683P; 55) NEURO SPINE CDS, REF CDS982683R; 56) NEURO SPINE CDS, REF CDS982683S; 57) NEURO SPINE CDS, REF CDS982683U; 58) NEURO SPINE CDS, REF CDS982683V; 59) NEURO SPINE, REF CDS982683W; 60) CRANIOTOMY, REF CDS982719P; 61) CRANIOTOMY, REF CDS982719Q; 62) CRANIOTOMY, REF CDS982719R; 63) CRANIOTOMY, REF CDS982719S; 64) CRANIOTOMY, REF CDS982719T; 65) CRANIOTOMY, REF CDS982719U; 66) CRANIOTOMY, REF CDS982719V; 67) CRANIOTOMY, REF CDS982719W; 68) ORTHO SPINE, REF CDS982735M; 69) ORTHO SPINE, REF CDS982735N; 70) ORTHO SPINE, REF CDS982735O; 71) ORTHO SPINE, REF CDS982735Q; 72) ORTHO SPINE, REF CDS982735R; 73) ORTHO SPINE, REF CDS982735S; 74) ORTHO SPINE, REF CDS982735U; 75) SPINAL CDS, REF CDS983037J; 76) SPINAL CDS, REF CDS983037K; 77) CRANIOTOMY CDS, REF CDS983094D; 78) CERVICAL SPINE CDS, REF CDS983108F; 79) LAMINECTOMY CDS, REF CDS983115F;...
- Reason
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 474300 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0794-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | In sequential order by REF Numbers as listed in product description: REF CDS780089V, UDI/DI 10193489587418 (EA) 40193489587419 (CS), Lot number 19BLA484; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19DBN638; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19EBN450; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19FBN031; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19JBE273; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19JBI710; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 19KBR616; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20BBQ409; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20CBP611; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20EBG877; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20EBS145; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20FBB178; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20FBR886; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 20JBH667; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21BBJ070; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21DBH746; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21HBJ414; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21IBA053; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21JBD207; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21KBC783; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21KBV808; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 21KBV809; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 22GBE917; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 22HBD316; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 22IBE293; REF CDS780102K, UDI/DI 10889942714506 (EA) 40889942714507 (CS), Lot number 22IBT392; REF CDS780102L, UDI/DI 10195327251000 (EA) 40195327251001 (CS), Lot number 23ABC312; REF CDS780102L, UDI/DI 10195327251000 (EA) 40195327251001 (CS), Lot number 23DBT155; REF CDS780102L, UDI/DI 10195327251000 (EA) 40195327251001 (CS), Lot number 23GBS654; REF CDS780102L, UDI/DI 10195327251000 (EA) 40195327251001 (CS), Lot number 24DBH404; REF CDS780102M, UDI/DI 10195327663636 (EA) 40195327663637 (CS), Lot number 24EBD650; REF CDS780102M, UDI/DI 10195327663636 (EA) 40195327663637 (CS), Lot number 24HBH456; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19CBB271; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19DBI491; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19EBB829; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19EBN421; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19FBD123; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19GBC919; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19IBH668; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 19JBR671; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20ABE319; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20CBC162; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20FBF445; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20GBD844; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20IBD944; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 20LBD264; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 21ABW337; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 21DBF100; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 21FBN763; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 21IBS477; REF CDS780105K, UDI/DI 10889942824700 (EA) 40889942824701 (CS), Lot number 21JBH424; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22CBG769; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22DBI992; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22EBE861; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22FBW180; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22GBA843; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22HBI798; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 22IBA597; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23ABD934; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23ABE600; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23DBD675; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23FBA008; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23FBA141; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23HBQ153; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23JBL140; REF CDS780105L, UDI/DI 10195327051877 (EA) 40195327051878 (CS), Lot number 23LBQ382; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24DBD154; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24DBO904; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24GBB610; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24HBP053; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24HBU251; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24HBW126; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24IBS790; REF CDS780105M, UDI/DI 10195327663407 (EA) 40195327663408 (CS), Lot number 24JBK737; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 22HBO015; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 22KBN442; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23ABF941; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23BBQ326; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23DBE182; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23GBQ904; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23JBS979; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 23LBD741; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24ABF767; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24BBK027; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24CBN697; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24DBR263; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24FBK934; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24GBU268; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24HBQ511; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24HBW819; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24IBB227; REF CDS780119V, UDI/DI 10195327114916 (EA) 40195327114917 (CS), Lot number 24IBL177; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19BBK880; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19CBL658; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19DBD742; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19EBU630; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19GBN522; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19HBM045; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19JBP877; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19KBH848; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 19LBR657; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20ABF337; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20ABW765; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20CBX811; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20DBK653; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20EBD439; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20EBJ889; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20GBL414; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20GBQ704; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20IBL449; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20IBS281; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 20JBY397; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21ABC393; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21ABF535; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21BBM815; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21EBK801; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21HBA493; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21IBO592; REF CDS780166Q, UDI/DI 10889942611737 (EA) 40889942611738 (CS), Lot number 21IBT365; REF CDS780205O, UDI/DI 10193489568424 (EA) 40193489568425 (CS), Lot number 19BKC139; REF CDS780205P, UDI/DI 10193489666342 (EA) 40193489666343 (CS), Lot number 19HKA583; REF CDS780205P, UDI/DI 10193489666342 (EA) 40193489666343 (CS), Lot number 19JKB108; REF CDS780205P, UDI/DI 10193489666342 (EA) 40193489666343 (CS), Lot number 19KKB462; REF CDS780205P, UDI/DI 10193489666342 (EA) 40193489666343 (CS), Lot number 19KKB600; REF CDS780205P, UDI/DI 10193489666342 (EA) 40193489666343 (CS), Lot number 20CKB378; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 20EKB234; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 20FKA999; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 20GKB432; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21AKB227; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21CKA935; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21GMF534; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21IME383; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21JMI174; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21KMD719; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 21KMH777; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 22GMA940; REF CDS780205Q, UDI/DI 10193489354836 (EA) 40193489354837 (CS), Lot number 24KMB743; REF CDS780206O, UDI/DI 10193489568448 (EA) 40193489568449 (CS), Lot number 19AKB597; REF CDS780206O, UDI/DI 10193489568448 (EA) 40193489568449 (CS), Lot number 19HKB050; REF CDS780206P, UDI/DI 10193489665680 (EA) 40193489665681 (CS), Lot number 19JKB227; REF CDS780206P, UDI/DI 10193... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 8, 2025
- Recall initiation date
- Nov 21, 2024
- Center classification date
- Dec 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.