PlainRecalls
FDA Devices Moderate Class II Ongoing

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF D

Reported: November 26, 2025 Initiated: September 30, 2025 #Z-0513-2026

Product Description

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

Reason for Recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Details

Recalling Firm
Medline Industries, LP
Units Affected
5133 kits
Distribution
US Nationwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled? ▼
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.. Recalled by Medline Industries, LP. Units affected: 5133 kits.
Why was this product recalled? ▼
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0513-2026.

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