FDAFDA · Food and drugs·Recall number Z-0635-2025
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Published December 11, 2024 · Recall initiated: October 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution.
- Lot
- 1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 40193489402774 (case), Lot Numbers: 22GBT396; 15) REF CDS983914K, UDI/DI 10193489402698 (each) 40193489402699 (case), Lot Numbers: 22EBA061, 22DBU743, 22GBI220; 16) REF CDS984599F, UDI/DI 10193489486148 (each) 40193489486149 (case), Lot Numbers: 22EMH743, 22HMA205, 22GMB332, 22KMF120, 22KMF139, 22HMF967, 23FME358, 23AMI307, 22LMF801, 23GMB934, 23KMF368, 23LMC668; 17) REF CDS984600F, UDI/DI 10193489486100 (each) 40193489486101 (case), Lot Numbers: 22JME533, 22HMH038, 23FMA360, 23EMI198, 23AMJ617, 23AMG705, 22LMI741, 23KMJ525, 23JMK211; 18) REF CDS984640G, UDI/DI 10195327435806 (each) 40195327435807 (case), Lot Numbers: 23IBD455, 23FBU659, 23JBF568, 23JBS933; 19) REF CDS984897J, UDI/DI 10193489983845 (each) 40193489983846 (case), Lot Numbers: 22KBM268; 20) REF CV6222T, UDI/DI 10193489314625 (each) 40193489314626 (case), Lot Numbers: 22ILA422, 23ILA216, 24ALA281, 23FLA764, 23DLA119; 21) REF DYNJ0101232F, UDI/DI 10195327028862 (each) 40195327028863 (case), Lot Numbers: 23DMI192, 23JBC628; 22) REF DYNJ0101285F, UDI/DI 10195327286569 (each) 40195327286560 (case), Lot Numbers: 23JDA016; 23) REF DYNJ0101339K, UDI/DI 10195327286583 (each) 40195327286584 (case), Lot Numbers: 23FDC341, 23EDC145, 23DDB460; 24) REF DYNJ0101435I, UDI/DI 10195327239473 (each) 40195327239474 (case), Lot Numbers: 23HMC631; 25) REF DYNJ0105614I, UDI/DI 10889942854165 (each) 40889942854166 (case), Lot Numbers: 23GBI709; 26) REF DYNJ0113967O, UDI/DI 10889942854189 (each) 40889942854180 (case), Lot Numbers: 23HBE512, 24ABO593; 27) REF DYNJ0161854D, UDI/DI 10195327304324 (each) 40195327304325 (case), Lot Numbers: 23DDB024, 23BDA412; 28) REF DYNJ0161949C, UDI/DI 10195327304331 (each) 40195327304332 (case), Lot Numbers: 22LDA230; 29) REF DYNJ01928K, UDI/DI 10195327491574 (each) 40195327491575 (case), Lot Numbers: 23KBI399; 30) REF DYNJ0259893T, UDI/DI 10195327356750 (each) 40195327356751 (case), Lot Numbers: 23DMA326; 31) REF DYNJ0282079U, UDI/DI 10195327589394 (each) 40195327589395 (case), Lot Numbers: 24ABX980, 24ABH203, 24DBV818, 24CBT374; 32) REF DYNJ0325443N, UDI/DI 10195327376055 (each) 40195327376056 (case), Lot Numbers: 23KBD218, 23GBI710; 33) REF DYNJ0378367R, UDI/DI 10195327494926 (each) 40195327494927 (case), Lot Numbers: 23JBD244, 23KBD947; 34) REF DYNJ0378388Q, UDI/DI 10195327500665 (each) 40195327500666 (case), Lot Numbers: 23JBV566; 35) REF DYNJ0426069L, UDI/DI 10195327058029 (each) 4019532
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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