Z-2500-2026Class II
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-04 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP... on . FDA classified it as Class II and gives the reason as "During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2500-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
- Product code
- OJG Neurological Tray
- Reason for recall
- During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 342 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Product codes and lots
- Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2479-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2480-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2481-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2482-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2483-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2484-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2485-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2486-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2487-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2488-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2489-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2490-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2491-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2492-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2493-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2494-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2495-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2496-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2497-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2498-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2499-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2500-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2501-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2502-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2503-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2504-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2505-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2506-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2507-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2508-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.