What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Medline Industries, LP recalled Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A. FDA's record states the reason for recall as: 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 logged under FDA recall number Z-2595-2026 with a Class II classification.

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

Key facts

Recalling firm	Medline Industries, LP
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Classification	Class II
Recall number	Z-2595-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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.

In short: Medline Industries, LP recalled Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A on 2026-07-01. FDA classified this action as a Class II recall (recall number Z-2595-2026). 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.. Recall status: Ongoing. This is a device-category FDA recall record.

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. PICC LINEPACK (PCLUI)642-LF DYNJ47717A. 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-2595-2026 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. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

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. PICC LINEPACK (PCLUI)642-LF DYNJ47717A -- and the recall number Z-2595-2026. 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. 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.

Medline Industries, LP’s FDA history

Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP: 0 warning letters, 293 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Medline Industries, LP recalled Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A. FDA's record states the reason for recall as: 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 logged under FDA recall number Z-2595-2026 with a Class II classification.
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.

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Full FDA history for Medline Industries, LP

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: Convenience kits containing select SKUs of 10mL Polycarbonate… by Medline Industries, LP — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2595-2026

MLA

"FDA Class II Recall: Convenience kits containing select SKUs of 10mL Polycarbonate… by Medline Industries, LP — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-medline-industries-lp-z-2595-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Convenience kits containing select SKUs of 10mL Polycarbonate… by Medline Industries, LP — Recall Details." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2595-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_medline_industries_lp_z_2595_2026_2026,
  title = {FDA Class II Recall: Convenience kits containing select SKUs of 10mL Polycarbonate… by Medline Industries, LP — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-medline-industries-lp-z-2595-2026},
  note = {Accessed: August 27, 2026}
}

Source: FDA.gov — Recalls ↗