Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGI…
Reason for recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B
Lot / code information
- UDI
- 10195327322984
- Lot #
- 23BMG740; DYNJ67987D
- UDI
- 10195327265496
- Lot #
- 22LMI014; DYNJ80317A
- UDI
- 10195327410780
- Lot #
- 23JLA076 DYNJ38412C
- UDI
- 10195327291792
- Lot #
- 24CME277 DYNJ66260A
- UDI
- 10195327185749
- Lot #
- 22GMH445 DYNJ44293I
- UDI
- 10198459152108 Lots 24JBX196 24KBJ077 24LBF062 24LBP058 DYNJ0854485W
- UDI
- 10195327403430
- Lot #
- 23EMI244 DYNJ82709
- UDI
- 10195327202590 Lots 22KBG072 23ABM307 23ABR612 DYNJ0261554AL
- UDI
- 10195327467760
- Lot #
- 23IMA846 DYNJ31103F
- UDI
- 10195327461317 Lots 23ILA143 23JLA420 23KLB055 23LLA790 24ALA692 24BLA009 24BLA835 24CLA859 24ELA213 24ELA684 24FLA287 24GLA266 24HLA117 24HLB121 24JLA570 24KLB094 24LLA468 25ALA377 DYNJ83506
- UDI
- 10195327272890
- Lot #
- 22LBM317 DYNJ66366C
- UDI
- 10195327232887 Lots 22HME111 22IME517 22JMF050 22LMH296 23DMD313 23EMF238 23FMH270 23GMF506 23HME060 SAMPC0686
- UDI
- 10195327195489
- Lot #
- 22HDA577 DYNJ63434B
- UDI
- 10195327335502 Lots 23CBG406 23CBU167 23DBT002 23EBS228 DYNJ907758B
- UDI
- 10195327181000
- Lot #
- 22GBD778 DYNJ80925B
- UDI
- 10195327624903
- Lot #
- 24CBG978
Show 17 more code fieldsShow fewer
What the firm is doing
This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
DistributionShow detailsHide
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2582-2026
- FDA device classification · OESOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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