MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF
Medical device recall Z-0649-2025. 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
- 252162 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: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL’S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425
252162 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
86OJF 1) REF CDS780112J, UDI/DI 10195327009663 (each) 40195327009664 (case), Lot Numbers: 22FBF455, 23CBH389, 23FBO500; 2) REF CDS780119V, UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 22KBN442, 22HBO015, 23ABF941,…
Every code shown here, 1,994 characters
86OJF 1) REF CDS780112J, UDI/DI 10195327009663 (each) 40195327009664 (case), Lot Numbers: 22FBF455, 23CBH389, 23FBO500; 2) REF CDS780119V, UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 22KBN442, 22HBO015, 23ABF941, 23DBE182, 23BBQ326; 3) REF CDS780147N, UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23DBT165, 22JBU233, 23BBJ852; 4) REF CDS780148Q, UDI/DI 10193489202939 (each) 40193489202930 (case), Lot Numbers: 22JBL294; 5) REF CDS780148R, UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23CBE921, 22LBL862, 23EBA185, 23EBU780; 6) REF CDS920027W, UDI/DI 10193489946956 (each) 40193489946957 (case), Lot Numbers: 22GBL731; 7) REF CDS920027X, UDI/DI 10195327241742 (each) 40195327241743 (case), Lot Numbers: 22JBF953; 8) REF CDS920027Y, UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23CBI608, 23CBF425; 9) REF CDS940047AF, UDI/DI 10195327243890 (each) 40195327243891 (case), Lot Numbers: 23DDC114, 23FDA378, 23IDA521, 23HDB417; 10) REF CDS940047AG, UDI/DI 10195327516710 (each) 40195327516711 (case), Lot Numbers: 23KDA158; 11) REF CDS940048AF, UDI/DI 10195327150259 (each) 40195327150250 (case), Lot Numbers: 22EDB749; 12) REF CDS940048AG, UDI/DI 10195327241896 (each) 40195327241897 (case), Lot Numbers: 22IDA258, 23CDB146, 23IDA944, 23HDA534; 13) REF CDS940048AI, UDI/DI 10195327516703 (each) 40195327516704 (case), Lot Numbers: 23KDA886; 14) REF CDS940072W, UDI/DI 10193489288544 (each) 40193489288545 (case), Lot Numbers: 22DBN494; 15) REF CDS940072Y, UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23EBG408, 23EBE750; 16) REF CDS940823AB, UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 22FBP685, 22GBM982, 22FBR756, 23CBS044, 23ABJ584, 22KBN648, 22JBL399, 23EBG438; 17) REF CDS940842Y, UDI/DI 10193489845129 (each) 40193489845120 (case), Lot Numbers: 23EBV624, 23DBT379; 18) REF CDS940843AA, UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 22EBD486, 22KBW061,…
FDA’s list runs to 140,171 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 140,171 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.