Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147... — FDA record Z-0530-2026
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 Sep 30, 2025. 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 convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP CDS, REF CDS940843AA; 9) TOTAL HIP CDS, REF CDS940963Y; 10) SHOULDER CDS, REF CDS941065L; 11) LAMINECTOMY CDS-LF, REF CDS981923X; 12) TOTAL KNEE CDS, REF CDS982823S; 13) LOWER EXTREMITY CDS, REF CDS982943S; 14) LOWER EXTREMITY CDS, REF CDS982943T; 15) TOTAL KNEE, REF CDS982986U; 16) EXTREMITY CDS, REF CDS983031Q; 17) PODIATRY CDS, REF CDS983610L; 18) TOTAL HIP CDS-LF, REF CDS983761N; 19) BASIC ORTHO CDS, REF CDS983769L; 20) UPPER EXTREMITY CDS, REF CDS983907L; 21) LOWER EXTREMITY CDS, REF CDS983909P; 22) GENERAL ORTHO CDS, REF CDS983915M; 23) MAJOR ORTHO, REF CDS984253L; 24) LOWER EXTREMTIY, REF CDS984254M; 25) TOTAL KNEE, REF CDS985566R; 26) ORTHO PACK, REF DYNJ00284M; 27) CRANIOTOMY PACK-LF, REF DYNJ0160354C; 28) CRANIOTOMY PACK-LF, REF DYNJ0161342C; 29) CRANIOTOMY PACK-LF, REF DYNJ0161342D; 30) CRANIOTOMY HARPER PACK-LF, REF DYNJ0162022G; 31) SPINE PACK-LF, REF DYNJ0376635P; 32) GP-TOTAL JOINT -LF, REF DYNJ0396868V; 33) GP-EXTREMITY/SHOULDER PACK-LF, REF DYNJ0396906P; 34) EXTREMITY PACK-LF, REF DYNJ0519273N; 35) TOTAL KNEE PACK-LF, REF DYNJ0530895AO; 36) TOTAL KNEE PACK-LF, REF DYNJ0530895AP; 37) UPPER EXTREMITY PACK-LF, REF DYNJ0532846S; 38) LOWER EXTREMITY PACK-LF, REF DYNJ0532852Q; 39) ACL SSC PACK-LF, REF DYNJ0536892U; 40) TOTAL HIP PACK-LF, REF DYNJ0536903AL; 41) TOTAL HIP PACK-LF, REF DYNJ0536903AM; 42) LOWER EXTREMITY PACK-LF, REF DYNJ0587115R; 43) TOTAL HIP PACK-LF, REF DYNJ0618354V; 44) TOTAL KNEE PACK-LF, REF DYNJ0646272S; 45) SPINE ANT POST ADD A PACK-LF, REF DYNJ0753208J; 46) OPEN SHOULDER SSC PACK, REF DYNJ0840659T; 47) TOTAL JOINT PACK-LF, REF DYNJ0885263F; 48) TOTAL KNEE PACK, REF DYNJ21813J; 49) CRANIO/MAXILOFACIAL #49-RF, REF DYNJ21826R; 50) TOTAL HIP PACK, REF DYNJ27315K; 51) PODIATRY PACK, REF DYNJ33978K; 52) LOWER EXTREMITY, REF DYNJ34420N; 53) LOWER EXTREMITY, REF DYNJ34420O; 54) GENERAL ORTHO, REF DYNJ34428O; 55) ARTHROSCOPY PACK, REF DYNJ35835G; 56) HAND PACK, REF DYNJ37697J; 57) ACH SPINE PACK, REF DYNJ38042K; 58) SHOULDER ARTHROSCOPY PACK, REF DYNJ38224C; 59) LAMINECTOMY PACK, REF DYNJ38227C; 60) EXTREMITY PACK, REF DYNJ38234G; 61) TOTAL JOINT PACK, REF DYNJ40982D; 62) SPINE PACK, REF DYNJ40995B; 63) EXTREMITY PACK, REF DYNJ41416G; 64) TOTAL JOINT PACK, REF DYNJ42793D; 65) CRANIOTOMY PACK-LF, REF DYNJ43208G; 66) HIP I PACK-LF, REF DYNJ43215I; 67) LAMINECTOMY PACK-LF, REF DYNJ43218G; 68) LIMB PACK-LF, REF DYNJ43220G; 69) SPLIT PACK-LF, REF DYNJ43225G; 70) TOTAL KNEE PACK-LF, REF DYNJ43226I; 71) EXTREMITY PACK, REF DYNJ44681J; 72) SHOULDER PACK, REF DYNJ44685L; 73) TOTAL KNEE PACK, REF DYNJ44687L; 74) UPPER EXTREMITY PACK, REF DYNJ44688I; 75) PODIATRY PACK, REF DYNJ44692G; 76) ACL PACK, REF DYNJ44849F; 77...
- Reason
- Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 40151 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0530-2026
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 | REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23GBQ904; REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23JBS979; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23LBD720; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24BBK043; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24CBA347; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24EBM283; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24GBB624; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23GBS348; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23HBJ325; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABK205; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABW098; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24BBN591; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24CBS634; REF CDS780208I: UDI/DI 10195327525231 (each) 40195327525232 (case), Lot Numbers: 23JBU709; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23LBF304; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24ABB904; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24CBA311; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23KBU712; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 24ABY634; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABQ717; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABU281; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24CBD739; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24DBP226; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24DBD229; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBM262; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBV396; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBO653; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBV236; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24CBS637; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24IBD594; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 23GBJ674; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24ABP205; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24CBD703; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24EBT843; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBB366; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBS882; REF CDS982823S: UDI/DI 10195327674403 (each) 40195327674404 (case), Lot Numbers: 24EBL031; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBA580; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBN648; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24DBW083; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24GBC807; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBJ387; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBQ432; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24ABP570; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24CBI682; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 24EBC693; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 23IBW098; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24BBB180; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24BBU600; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24CBN838; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24EBT875; REF CDS983031Q: UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 24FBS402; REF CDS983610L: UDI/DI 10195327210151 (each) 40195327210152 (case), Lot Numbers: 23HBC818; REF CDS983610L: UDI/DI 10195327210151 (each) 40195327210152 (case), Lot Numbers: 24DBE385; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBC403; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBM156; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23JBU065; REF CDS983761N: UDI/DI 10195327473662 (each) 40195327473663 (case), Lot Numbers: 23LBD278; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23HBP622; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23JBC159; REF CDS983769L: UDI/DI 10195327451196 (each) 40195327451197 (case), Lot Numbers: 23KBP622; REF CDS983907L: UDI/DI 10195327238346 (each) 40195327238347 (case), Lot Numbers: 23IBC640; REF CDS983907L: UDI/DI 10195327238346 (each) 40195327238347 (case), Lot Numbers: 23LBM312; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23IBW039; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23JBB094; REF CDS983909P: UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 23LBK752; REF CDS983915M: UDI/DI 10195327238353 (each) 40195327238354 (case), Lot Numbers: 24ABG846; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24ABD711; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24ABP282; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24BBI150; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24CBS643; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24DBK828; REF CDS984253L: UDI/DI 10193489288513 (each) 40193489288514 (case), Lot Numbers: 24EBP547; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 23HBD301; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24ABT691; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24BBS781; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24DBS099; REF CDS984254M: UDI/DI 10195327415242 (each) 40195327415243 (case), Lot Numbers: 24EBF862; REF CDS985566R: UDI/DI 10198459014758 (each) 40198459014759 (case), Lot Numbers: 24GBH839; REF DYNJ00284M: UDI/DI 10195327412036 (each) 40195327412037 (case), Lot Numbers: 23GMA018; REF DYNJ00284M: UDI/DI 10195327412036 (each) 40195327412037 (case), Lot Numbers: 24AMC690; REF DYNJ0160354C: UDI/DI 10195327320072 (each) 40195327320073 (case), Lot Numbers: 23GDA315; REF DYNJ0160354C: UDI/DI 10195327320072 (each) 40195327320073 (case), Lot Numbers: 23GDB867; REF DYNJ0161342C: UDI/DI 10195327357269 (each) 40195327357260 (case), Lot Numbers: 23EDA760; REF DYNJ0161342D: UDI/DI 10195327478506 (each) 40195327478507 (case), Lot Numbers: 23HDB481; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23FDB286; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23GDA631; REF DYNJ0162022G: UDI/DI 10195327404598 (each) 40195327404599 (case), Lot Numbers: 23HDA239; REF DYNJ0376635P: UDI/DI 10195327532987 (each) 40195327532988 (case), Lot Numbers: 24AMB890; REF DYNJ0396868V: UDI/DI 10195327454258 (each) 40195327454259 (case), Lot Numbers: 23GDB690; REF DYNJ0396906P: UDI/DI 10195327454197 (each) 40195327454198 (case), Lot Numbers: 23HDB063; REF DYNJ0396906P: UDI/DI 10195327454197 (each) 40195327454198 (case), Lot Numbers: 23JDB511; REF DYNJ0519273N: UDI/DI 10195327083472 (each) 40195327083473 (case), Lot Numbers: 23EMA335; REF DYNJ0530895AO: UDI/DI 10193489782790 (each) 40193489782791 (case), Lot Numbers: 24ABS237; REF DYNJ0530895AP: UDI/DI 10195327628550 (each) 40195327628551 (case), Lot Numbers: 24CBJ626; REF DYNJ0530895AP: UDI/DI 10195327628550 (each) 40195327628551 (case), Lot Numbers: 24DBH846; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23JME365; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23KMF703; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 23KMJ025; REF DYNJ0532846S: UDI/DI 10195327356781 (each) 40195327356782 (case), Lot Numbers: 24AMI561; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 23JMC960; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 23LMA587; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24BMJ693; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24BMJ826; REF DYNJ0532852Q: UDI/DI 10195327356705 (each) 40195327356706 (case), Lot Numbers: 24DMK245; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 23HBH153; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 24DBH427; REF DYNJ0536892U: UDI/DI 10195327206239 (each) 40195327206230 (case), Lot Numbers: 24DBI493; REF DYNJ0536903AL: UDI/DI 10193489782783 (each) 40193489782784 (case), Lot Numbers: 24ABK586; REF DYNJ0536903AM: UDI/DI 10195327628567 (each) 40195327628568 (case), Lot Numbers: 24DBA383; REF DYNJ0536903AM: UDI/DI 10195327628567 (each) 40195327628568 (case), Lot Numbers: 24JBS809; REF DYNJ0587115R: UDI/DI 10195327561888 (each) 40195327561889 (case), Lot Numbers: 24BBP114; REF DYNJ0587115R: UDI/DI 10195327561888 (each) 40195327561889 (case), Lot Numbers: 24DBO138; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 23GBG269; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 23GMC905; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 24ABH235; REF DYNJ0618354V: UDI/DI 10889942860760 (each) 40889942860761 (case), Lot Numbers: 24CBR569; REF DYNJ0646272S: UDI/DI 10889942860920 (each) 40889942860921 (case), Lot Numbers: 23KBU390; REF DYNJ0646272S: UDI/DI 10889942860920 (each) 40889942860921 (case), Lot Numbers: 24CBU458; REF DYNJ0753208J: UDI/DI 10195327689896 (each) 40195327689897 (case), Lot Numbers: 24FME095; REF DYNJ0840659T: UDI/DI 10195327206512 (each) 40195327206513 (case), Lot Numbers: 23LBS322; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 23JMG075; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 23KMI286; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 24AMH655; REF DYNJ0885263F: UDI/DI 10195327219635 (each) 40195327219636 (case), Lot Numbers: 24CMC882; REF DYNJ21813J: UDI/DI 10195327515867 (each) 40195327515868 (case), Lot Numbers: 23JBE704; REF DYNJ21813J: UDI/DI 10195327515867 (each) 40195327515868 (case), Lot Numbers: 24ABV081; REF DYNJ21826R: UDI/DI 10195327104412 (each) 40195327104413 (case), Lot Numbers: 23LBA701; REF DYNJ27315K: UDI/DI 10195327515966 (each) 40195327515967 (case), Lot Numbers: 23KBC303; REF DYNJ33978K: UDI/DI 10195327436315 (each) 40195327436316 (case), Lot Numbers: 23GBR447; REF DYNJ33978K: UDI/DI 10195327436315 (each) 40195327436316 (case)... |
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
US Nationwide distribution.
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
- Nov 26, 2025
- Recall initiation date
- Sep 30, 2025
- Center classification date
- Nov 14, 2025
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.