MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY
Medical device recall Z-0630-2025. Published in FDA’s Enforcement Report on Dec 11, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 11, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 167074 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
167074 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 1,995 characters
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) 40195327079087 (case), Lot Numbers: 22GBZ014, 22GBD101; 12) REF CDS920080S, UDI/DI 10195327209605 (each) 40195327209606 (case), Lot Numbers: 23ABK590, 22JBO105; 13) REF CDS920080T, UDI/DI 10195327349486 (each) 40195327349487 (case), Lot Numbers: 23EBB523; 14) REF CDS930027U, UDI/DI 10193489288537 (each) 40193489288538 (case), Lot Numbers: 22FBY534; 15) REF CDS930027V, UDI/DI 10195327241759 (each) 40195327241750 (case), Lot Numbers: 22JBR529, 22JBJ699, 23CBP730, 23ABL590, 23FBV023; 16) REF CDS930120G, UDI/DI 10195327009649 (each) 40195327009640 (case), Lot Numbers: 22FBV562, 22IBU622, 22KBI260, 22LBT330, 23HBS920, 23HBS779, 23ABQ984, 23EBD647, 23JBJ078; 17) REF CDS930120I, UDI/DI 10195327533342 (each) 40195327533343 (case), Lot Numbers: 23KBP659; 18) REF CDS930121L, UDI/DI 10195327065423 (each)…
FDA’s list runs to 48,473 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 9, 2024.
- FDA classified it on Dec 5, 2024.
- FDA’s Enforcement Report published it on Dec 11, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 48,473 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.