Medline convenience kits labeled as LOCAL BASIC (REF DYNJ34418M) and numerous other Medline convenience kits identified by product name, REF/UDI and lot numbers are affected; the recall covers kits that contain SafeAir Smoke Evacuation Pencils. The kits were recalled because Stryker expanded its SafeAir pencil recall after the devices could potentially activate without manual input when plugged in or remain active after buttons are released.
What's being recalled
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
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…
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK…
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF CDS920080T; 8) GENERAL LAPAROSCOPY, REF CDS930027V; 9) GENERAL LAPAROSCOPY, REF CDS930027X; 10) GENERAL MINOR CDS, REF CDS980246V; 11) BASIC CDS, REF CDS982936V; 12) MAJOR ABDOMINAL CDS, REF CDS983759L; 13) GENERAL SURGERY CDS, REF CDS983914L; 14) GENERAL LAP, REF CDS984251N; 15) ACH MINOR PROCEDURE, REF CDS985451G; 16) SCOPE LAP THOR PACK, REF DYNJ00210N; 17) MAJOR LAPAROTOMY PACK, REF…
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC…
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF…
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF…
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
And 5 more products.
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
UDI/DI 10195327384371 (each), 40195327384372 (case), Lot Numbers: 24CBO120, 24DBA216 UDI/DI 10195327333256 (each), 40195327333257 (case), Lot Numbers: 23KLA460 1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)