HTM Vibe
← Back to recalls

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.

Class II
Recalling firm
Medline Industries, LP
Reason for recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Affected products (lot / model / serial)
Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMF181; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMD186; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26CMA323; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26BMJ234; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 26ALA854; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADB485; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADA395; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 26ABM111; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25LBH825; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMC475; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMB629; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25KLA526; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25KBP981; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25JDB519; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25JBI857; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25IMC513; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ILA706; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25IDB222; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25IBP736; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25HLA065; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25HBO604; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25GDB198; Medline Product Number/SKU DYNJ905276F, UDI/DI 10198459247965 (each) 40198459247966 (case), Lot Number 25GBS381; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25GBQ923; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25GBJ981; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25FLA160; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25FDA332; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25FBN175; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25EBV301; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25EBH152; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25DLA962; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25DDB837; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25DDA286; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25DBC339; Medline Prod
Units affected
6069 kits
Distribution pattern
US Nationwide distribution.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-0179-2027
Recall initiated
September 2, 2026
FDA classification date
October 15, 2026
FDA report date
October 21, 2026
FDA event ID
99886
Last updated on HTM Vibe
October 27, 2026
View on openFDA