MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF
Medical device recall Z-0625-2025. 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
- 30092 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) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK, REF CDS840459R; 8) CAROTID-LF, REF CDS860039K; 9) CAROTID-LF, REF CDS860039L; 10) OPEN HEART ADULT KIT, REF CDS981319AD; 11) BAPTIST AAA, REF CDS982400M; 12) ZALE PUMP CDS, REF CDS983187G; 13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G; 14) MAJOR VASCULAR, REF CDS983489K; 15) CAROTID, REF CDS983495N; 16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 17) AV FISTULA, REF CDS983638K; 18) PERIPHERAL VASCULAR CDS, REF CDS983723I; 19) ACH OPEN HEART, REF CDS983773J; 20) VASCULAR, REF CDS984255K; 21) VASCULAR CDS, REF CDS984275I; 22) OPEN HEART CDS, REF CDS984276O; 23) OPEN HEART CDS, REF CDS984355G; 24) OPEN HEART CDS, REF CDS984355I; 25) SMH VASCULAR CDS, REF CDS984584M; 26) VASCULAR CDS-LF, REF CDS984594G; 27) VASCULAR CDS-LF, REF CDS984594I; 28) VASCULAR, REF CDS985355F; 29) SJ BYPASS LEG CUSTOM PACK-LF, REF DYNJ0042944J; 30) SJ BYPS LEG CSTM PK RFID-LF, REF DYNJ0042944K; 31) AV FISTULA PACK-LF, REF DYNJ0131782G; 32) AV FISTULA PACK-LF, REF DYNJ0131782I; 33) AV FISTULA PACK-LF, REF DYNJ0131782J; 34) AV FISTULA PACK-LF, REF DYNJ0131782K; 35) VASCULAR PACK, REF DYNJ02467M; 36) OPEN HEART PACK A & B, REF DYNJ0283397U; 37) VASCULAR PACK-LF, REF DYNJ0421380P; 38) MAJOR VASCULAR PACK-LF, REF DYNJ0488546J; 39) SJ CARDIAC A PACK RFID-LF, REF DYNJ0619768M; 40) SJ PACEMAKER PACK RFID-LF, REF DYNJ0619848O; 41) PACEMAKER PACK-LF, REF DYNJ0826630N; 42) AV SHUNT PACK-LF, REF DYNJ0842516G; 43) GENERAL ENDO PACK-LF, REF DYNJ0842873K; 44) PACEMAKER PACK-LF, REF DYNJ0843217M; 45) PACEMAKER PACK-LF, REF DYNJ0843217N; 46) PACEMAKER PACK-LF, REF DYNJ0867353I; 47) PACEMAKER PACK-LF, REF DYNJ0867353J; 48) CAROTID ARTERY PACK-LF, REF DYNJ0882509L; 49) CAROTID ARTERY PACK-LF, REF DYNJ0882509N; 50) VASCULAR PACK-LF, REF DYNJ0901358J; 51) VASCULAR PACK-LF, REF DYNJ0901358K; 52) HEALTH ALL VASCULAR PACK-LF, REF DYNJ19538F; 53) OPEN HEART A&B PK-LF, REF DYNJ20888K; 54) OPEN HEART A&B PK-LF, REF DYNJ20888L; 55) GEN FEM POP #14-RF, REF DYNJ21877W; 56) CABG PACK A&B, REF DYNJ21971AD; 57) VASCULAR PACK, REF DYNJ22350L; 58) SVMMC CORE OPEN HEART PACK-LF, REF DYNJ22971T; 59) OPEN HEART SUPPLEMENT A, REF DYNJ24591AB; 60) SVMMC OPEN HEART ADD ON PACK, REF DYNJ24634O; 61) SVMMC PERMANENT PACING PACK, REF DYNJ24746I; 62) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 63) PACEMAKER PACK, REF DYNJ30928O; 64) VASCULAR PACK, REF DYNJ31902N; 65) DB CAROTID PACK-LF, REF DYNJ33579F; 66) DB ENDOVASCULAR AAA PACK-LF, REF DYNJ33689I; 67) PACEMAKER ICD PK, REF DYNJ34795K; 68) OPEN HEART PACK A&B, REF DYNJ35854D; 69) PACEMAKER PACK, REF DYNJ36025D; 70) RRMC PACEMAKER PACK, REF DYNJ36337G; 71) OPEN HEART PACK, REF DYNJ37284J; 72) PACEMAKER PACK, REF DYNJ37557D; 73) PEDIATRIC CARDIAC MINOR, REF DYNJ37618D; 74) ACH CABG ADD-ON, REF DYNJ38175L; 75) PACEMAKER SET UP PACK, REF DYNJ38232B; 76) PACEMAKER PACK-LF, REF DYNJ38643F; 77) PACEMAKER PACK-LF, REF DYNJ38702A; 78) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439K; 79) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439L; 80) CARDIOVASCULAR PACK, REF DYNJ42921G; 81) CABG PACK-LF, REF DYNJ43207K; 82) HEART DRAPING PACK-LF, REF DYNJ43214F; 83) VASCULAR PACK, REF DYNJ43276I; 84) SVMMC VASCULAR MAJOR PACK, REF DYNJ43777J; 85) OPEN HEART PACK A AND B, REF DYNJ43858B; 86) SVMMC CAROTID PACK, REF DYNJ43861F; 87) MAJOR VASCULAR PACK, REF DYNJ44161G; 88) MINOR VASCULAR PACK, REF DYNJ44164F; 89) VASCULAR ACCESS PACK, REF DYNJ44172D; 90) AV FISTULA PACK, REF DYNJ44704J; 91) AAA PACK, REF DYNJ44847I; 92) CARDIAC VASCULAR PACK, REF DYNJ44854M; 93) CASTRO CABG-COMPONENT PACK, REF DYNJ44857S; 94) CASTRO CABG-COMPONENT PACK, REF DYNJ44857T; 95) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 96) FIST
30092 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) REF CDS840232L, UDI/DI 10195327013691 (each) 40195327013692 (case), Lot Numbers: 22FBF374, 22FBX255, 23EBQ492, 23CBW366, 23CBW387, 23IBS976; 2) REF CDS840233I, UDI/DI 10195327065270 (each) 40195327065271 (case), Lot Numbers: 22GBJ144,…
Every code shown here, 2,000 characters
1) REF CDS840232L, UDI/DI 10195327013691 (each) 40195327013692 (case), Lot Numbers: 22FBF374, 22FBX255, 23EBQ492, 23CBW366, 23CBW387, 23IBS976; 2) REF CDS840233I, UDI/DI 10195327065270 (each) 40195327065271 (case), Lot Numbers: 22GBJ144, 22FBO691, 22HBS387, 23BBG362, 23DBD583, 23GBU961, 23GBU784; 3) REF CDS840261AB, UDI/DI 10195327104535 (each) 40195327104536 (case), Lot Numbers: 22FBX514, 22IBE745, 23ABG192, 22KBO918, 23DBE827; 4) REF CDS840387T, UDI/DI 10195327070946 (each) 40195327070947 (case), Lot Numbers: 22FBS963, 22HBO062; 5) REF CDS840402AF, UDI/DI 10195327144029 (each) 40195327144020 (case), Lot Numbers: 22ELB107, 22ELA850, 22FLA766; 6) REF CDS840402AI, UDI/DI 10195327334024 (each) 40195327334025 (case), Lot Numbers: 23DLA845, 23GLA701, 23GLA627, 23HLA275, 23LLA792; 7) REF CDS840459R, UDI/DI 10195327194598 (each) 40195327194599 (case), Lot Numbers: 22HBR722, 23IBD831, 23IBD869, 23JBR310; 8) REF CDS860039K, UDI/DI 10195327009397 (each) 40195327009398 (case), Lot Numbers: 22FBF456, 23ABP502, 23DBE091, 23HBU269; 9) REF CDS860039L, UDI/DI 10195327533281 (each) 40195327533282 (case), Lot Numbers: 23KBT206; 10) REF CDS981319AD, UDI/DI 10195327547226 (each) 40195327547227 (case), Lot Numbers: 24AMI772; 11) REF CDS982400M, UDI/DI 10195327034566 (each) 40195327034567 (case), Lot Numbers: 23JBB859, 23KBT042, 24CBH306; 12) REF CDS983187G, UDI/DI 10195327258528 (each) 40195327258529 (case), Lot Numbers: 23EBK193, 23BBN996, 23BBN811, 23ABC476, 23EBG037; 13) REF CDS983481G, UDI/DI 10195327497347 (each) 40195327497348 (case), Lot Numbers: 23LDA076, 23KDC290, 24BDA534, 24DDA867; 14) REF CDS983489K, UDI/DI 10195327497279 (each) 40195327497270 (case), Lot Numbers: 24ADA159; 15) REF CDS983495N, UDI/DI 10195327497323 (each) 40195327497324 (case), Lot Numbers: 23KDB048, 24ADB582; 16) REF CDS983637I, UDI/DI 10195327228125 (each) 40195327228126 (case), Lot Numbers: 22LBC194, 22KBC672, 23ABM692; 17) REF CDS983638K, UDI/DI 10195327228132 (each) 40195327228133 (case), Lot Numbers:…
FDA’s list runs to 29,220 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 29,220 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.