Z-1157-2024Class II

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

Name: Z-1157-2024 Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-01-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-01-04 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe on 2024-01-04. FDA classified it as Class II and gives the reason as "Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1157-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-04
Posted: 2024-09-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Product code: KYZ Syringe, Irrigating (Non Dental)
Reason for recall: Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704
Quantity in commerce: 4831 units
Distribution: US, Nationwide
Product codes and lots: UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-02-16

Product code KYZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)