FDA Device recall Z-0179-2027
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM by Medline Industries, citing 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 duri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0179-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-02 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medli…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 (ca |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Medline Industries
- Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC
FDA Device · Class II · 2026-10-21 · Medline Industries - Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &
FDA Device · Class II · 2026-10-21 · Medline Industries
All Medline Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0179-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.