Z-1410-2026Class II
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-01-07 / Open, Classified / root cause: packaging
Medline Industries, LP began a recall of Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A on . FDA classified it as Class II and gives the reason as "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1410-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
- Product code
- NSB Patient Personal Hygiene Kit
- Reason for recall
- Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 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. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,
- Quantity in commerce
- 1070 units
- Distribution
- Worldwide distribution - US Nationwide.
- Product codes and lots
- 1) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1384-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1385-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1386-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1387-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1388-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1389-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1390-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1391-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1392-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1393-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1394-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1395-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1396-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1397-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1398-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1399-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1400-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1401-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1402-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1403-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1404-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1405-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1406-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1407-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1408-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1409-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1410-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1411-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1412-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1413-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1414-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1415-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1416-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1417-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1418-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1419-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1420-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1421-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1422-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1423-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1424-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1425-2026 | 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.