FDA Class II Recall: Convenience kits containing select SKUs of 10mL Polycarbonate… by Medline Industries, LP — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Medline Industries, LP and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.. The recall is tracked under FDA recall number Z-2582-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with 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 (additional items listed in FDA's full record) -- and the recall number Z-2582-2026. If it matches, stop using or distributing it and contact Medline Industries, LP or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Medline Industries, LP’s FDA history

Argus HQ has recorded 242 total FDA actions tied to Medline Industries, LP: 0 warning letters, 242 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed in FDA's full record)) and recall number Z-2582-2026, then follow Medline.

Has Medline Industries, LP had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 242 total FDA actions tied to Medline Industries, LP, including 242 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2582-2026.

Related enforcement actions