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

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityIn 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.

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.

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