CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Convenience kits containing select SKUs of Polycarbonate recalled
Medline Industries is recalling Convenience kits containing select SKUs of Polycarbonate Colored Syringes, distributed nationwide in the US. The recall was initiated on 27 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2582-2026
- FDA event ID
- 99062
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2026
- FDA classified
- 25 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 27 Feb 2026 | Recall initiated by company | |
| 25 Jun 2026 | Classified by FDA | +118 days |
| 1 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontanaNebraska
Questions about this recall
Why was it recalled?
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Which lots are affected?
DYNJ43609S UDI-DI 10195327322984 Lot 23BMG740; DYNJ67987D UDI-DI 10195327265496 Lot 22LMI014; DYNJ80317A UDI-DI 10195327410780 Lot 23JLA076 DYNJ38412C UDI-DI 10195327291792 Lot 24CME277 DYNJ66260A UDI-DI 10195327185749 Lot 22GMH445 DYNJ44293I UDI-DI 10198459152108 Lots 24JBX196 24KBJ077 24LBF062 24LBP058 DYNJ0854485W UDI-DI 10195327403430 Lot 23EMI244 DYNJ82709 UDI-DI 10195327202590 Lots 22KBG072 23ABM307 23ABR612 DYNJ0261554AL UDI-DI 10195327467760 Lot 23IMA846 DYNJ31103F UDI-DI 10195327461317 Lots 23ILA143 23JLA420 23KLB055 23LLA790 24ALA692 24BLA009 24BLA835 24CLA859 24ELA213 24ELA684 24FLA287 24GLA266 24HLA117 24HLB121 24JLA570 24KLB094 24LLA468 25ALA377 DYNJ83506 UDI-DI 10195327272890 Lot 22LBM317 DYNJ66366C UDI-DI 10195327232887 Lots 22HME111 22IME517 22JMF050 22LMH296 23DMD313 23EMF238 23FMH270 23GMF506 23HME060 SAMPC0686 UDI-DI 10195327195489 Lot 22HDA577 DYNJ63434B UDI-DI 10195327335502 Lots 23CBG406 23CBU167 23DBT002 23EBS228 DYNJ907758B UDI-DI 10195327181000 Lot 22GBD778 DYNJ80925B UDI-DI 10195327624903 Lot 24CBG978
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 99062This product is part of a recall event; the main page for the event is Convenience kits containing select SKUs of Polycarbonate recalled.
More recalls from Medline Industries
All 707| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |
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|---|---|---|---|---|---|
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