Recall Z-0630-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated October 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 77) LAPAROTOMY PACK-LF, REF DYNJ0366425N; 78) MAJOR PACK-LF, REF DYNJ0386381L; 79) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 80) LAPAROSCOPY GYN PACK, REF DYNJ05175M; 81) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 82) MINOR PACK-LF, REF DYNJ0531958S; 83) MAJOR PACK-LF, REF DYNJ0531964X; 84) LAP CHOLE PACK-LF, REF DYNJ0537278AD; 85) LAP/CHOLE PACK-LF, REF DYNJ0589896R; 86) LAP/CHOLE PACK-LF, REF DYNJ0589896S; 87) LAP/CHOLE PACK-LF, REF DYNJ0589896T; 88) LAP/CHOLE PACK-LF, REF DYNJ0589896U; 89) LAP/CHOLE PACK-LF, REF DYNJ0589896V; 90) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913K; 91) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913M; 92) LKLND LP CHL PK RFID-LF, REF DYNJ0619913N; 93) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401Q; 94) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401R; 95) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 96) MAJOR LAPAROTOMY PACK-LF, REF DYNJ0751444S; 97) MAJO
Codes / lots: 1) REF CDS760057J, UDI/DI 10195327008963 (each) 40195327008964 (case), Lot Numbers: 22FBX954, 22FBE976; 2) REF CDS760057K, UDI/DI 10195327274368 (each) 40195327274369 (case), Lot Numbers: 23ABU244, 22LBC409, 23GBN928, 23CBO552, 23EBA183, 23JBH987; 3) REF CDS760057L, UDI/DI 10195327533373 (each) 40195327533374 (case), Lot Numbers: 23KBL294; 4) REF CDS860015W, UDI/DI 10195327349509 (each) 40195327349500 (case), Lot Numbers: 23FBP597; 5) REF CDS860016P, UDI/DI 10193489848007 (each) 40193489848008 (case), Lot Numbers: 22FBQ637; 6) REF CDS860016Q, UDI/DI 10195327209599 (each) 40195327209590 (case), Lot Numbers: 23ABM653, 22KBA835, 22JBE511; 7) REF CDS860016R, UDI/DI 10195327349479 (each) 40195327349470 (case), Lot Numbers: 23GBD634; 8) REF CDS860062R, UDI/DI 10193489852073 (each) 40193489852074 (case), Lot Numbers: 22OBE627, 22OBA906; 9) REF CDS860062S, UDI/DI 10195327140632 (each) 40195327140633 (case), Lot Numbers: 22GBS435, 22GBO814, 23ABG350, 23DBG817, 23EBQ675; 10) REF CDS860194I, UDI/DI 10193489445152 (each) 40193489445153 (case), Lot Numbers: 22GBN008, 23BBR005, 22LBJ448, 22JBH327, 23GBL900, 23GBM243, 23DBE016, 22KBK702; 11) REF CDS920080R, UDI/DI 10195327079086 (each)…
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
FDA-determined cause: Under Investigation by firm
Action taken
Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
Details
- Recall number
- Z-0630-2025
- Initiated
- October 9, 2024
- Posted by FDA
- December 5, 2024
- Product code
- FDE – Laparoscopy Kit
- Quantity
- 167074 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0622-2025 Class II | MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0623-2025 Class II | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0624-2025 Class II | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0625-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0626-2025 Class II | MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0627-2025 Class II | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0628-2025 Class II | MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0629-2025 Class II | MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0631-2025 Class II | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0632-2025 Class II | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0633-2025 Class II | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0634-2025 Class II | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0635-2025 Class II | Refer to RES or lead review memo for complete list of affected reference/catalog numbersMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0636-2025 Class II | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BMedline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0637-2025 Class II | MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0638-2025 Class II | MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0639-2025 Class II | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0640-2025 Class II | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0641-2025 Class II | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0642-2025 Class II | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0643-2025 Class II | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0644-2025 Class II | MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0645-2025 Class II | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0646-2025 Class II | MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0647-2025 Class II | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0648-2025 Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |
| Z-0649-2025 Class II | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | 10/09/2024Open, Classified |