Z-1832-2026Class II
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-25 / Open, Classified
Medline Industries, LP began a recall of Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D on . FDA classified it as Class II and gives the reason as "The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1832-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
- Product code
- OGJ Nerve Block Tray
- Reason for recall
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDA root cause
- No Marketing Application
- Action
- An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or [email protected]. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter
- Quantity in commerce
- 15 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 1) DYNJ24517D, UDI-DI: 10193489812510(each), 40193489812511(case), Lot Number: 25CBA224
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1829-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1830-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1831-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1832-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1833-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1834-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1835-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1836-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1837-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1838-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1839-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1840-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1841-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1842-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1843-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1844-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1845-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1846-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1847-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1848-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1849-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1850-2026 | 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.