PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

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 CD

Reported: December 11, 2024 Initiated: October 9, 2024 #Z-0625-2025 30092 units units

MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on December 11, 2024. Classified as Moderate severity (Class II). Approximately 30092 units units are affected. The recall was issued because: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0625-2025) was formally reported on December 11, 2024, with the manufacturer initiating the action on October 9, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 30092 units units are affected.

The documented reason for this recall is: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

30092 units

Related Recalls

6

6 from same agency

Product Description

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

Reason for Recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Details

Units Affected
30092 units
Distribution
US Nationwide distribution.
Location
Northfield, IL

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-0625-2025
Date reported December 11, 2024
Date initiated October 9, 2024
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Units affected 30092 units
Distribution US Nationwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

30092 units units affected — limited or regional distribution scale.

Regional (<10K units) —
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) —
Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was 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. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 30092 units.
Why was this product recalled? ▼
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0625-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0625-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

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All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).