Z-2504-2026Class II
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV...
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) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C 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-2504-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
- Product code
- OHM Cesarean Section 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
- 168 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 Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMC247; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMB678; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21IMH919; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24CBO389; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24ABR872.
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.