Z-1546-2020Class II

Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01)...

Name: Z-1546-2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01)...
Creator: Medline Industries Inc
Published: 2020-02-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-02-10 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153 on 2020-02-10. FDA classified it as Class II and gives the reason as "Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1546-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-10
Posted: 2020-03-20
Terminated: 2023-02-13
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Product code: LRO General Surgery Tray
Reason for recall: Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medline notified customers on February 18, 2020 via "Urgent Recall Immediate Action required" letter. The consignees were instructed to complete the response form and return the product. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Quantity in commerce: 3,690 units
Distribution: US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.
Product codes and lots: REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1545-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20
Z-1546-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code LRO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)