Recall Record: Class II Recall: Medline Convenience Kits containing select SKUs of 10mL… by Medline Industries, LP

Key facts

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 -- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT (additional items listed in FDA's full record) -- and the recall number Z-1878-2026. 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.

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: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT (additional items listed in FDA's full record). FDA's stated reason for the recall is: Unapproved design changes to the products outside of the 510(k) clearance.. The recall is tracked under FDA recall number Z-1878-2026 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.

Medline Industries, LP’s FDA history

Argus HQ has recorded 269 total FDA actions tied to Medline Industries, LP: 0 warning letters, 269 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

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 (Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT (additional items listed in FDA's full record)) and recall number Z-1878-2026, then follow Medline Industries.

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

Yes. Argus HQ has recorded 269 total FDA actions tied to Medline Industries, LP, including 269 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1878-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions

• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP101… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESI… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L… →