Use caution Medical device recall · FDA · Published September 17, 2024

Zimmer Saphena Medical Venapax XL Recall: Endoscope Slot Misalignment Risk

Zimmer recalls Saphena Medical Venapax XL endoscopic vessel harvesting systems due to potential endoscope slot misalignment causing surgical interference. Affected units have specific lot numbers and item codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0285-2025Medical device Zimmer ›

Use caution until it’s fixed

A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery

Take action

Contact the company

Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304

✎ GovInfoNow plain-language explainer

Zimmer is recalling Saphena Medical Venapax XL endoscopic vessel harvesting systems because a manufacturing error caused the endoscope slot to be misaligned with the tail piece. This could lead to surgical complications during minimally invasive procedures. Read more at govinfonow.com/recall/54014-zimmer-saphena-medical-venapax-xl-recall-endoscope-slot-misalignment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54014-zimmer-saphena-medical-venapax-xl-recall-endoscope-slot-misalignment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0285-2025

Cite this page

“Zimmer Saphena Medical Venapax XL Recall: Endoscope Slot Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54014-zimmer-saphena-medical-venapax-xl-recall-endoscope-slot-misalignment-risk. Based on FDA recall #Z-0285-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0285-2025%22&limit=1).

The FDA announced on 2024-09-17 that Zimmer, Inc. is recalling the Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System due to a manufacturing defect. The hazard involves an interference fit that may cause extension during surgery.

How to tell if you have it

Brand: Zimmer
Product: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System
Item Number: VPX4000 (7273)
UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J
Lot Numbers: 43DD6738, 43DD8092
Units affected: 432

The hazard

Context

GovInfoNow's records show Zimmer, Inc. has had 19 other recalls on record since 2022-08-25. Recent similar recalls include the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (2026-05-22), the Medtronic Octopus Nuvo Tissue Stabilizer Recall (2026-01-13), and the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03).

How to tell if you have this one

Check for item number VPX4000 (7273) with UDI codes +M718VPX40001/$$326051543DD6738Q or +M718VPX40001/$$326062143DD8092J. Lot numbers 43DD6738 and 43DD8092 are affected.

Brand
Zimmer
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Verify the item number and UDI codes to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 57 days after the firm started it.

Sep 17, 2024Firm started the recall
Nov 1, 2024FDA classified it Class II
Nov 13, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54014-zimmer-saphena-medical-venapax-xl-recall-endoscope-slot-misalignment-risk">Zimmer Saphena Medical Venapax XL Recall: Endoscope Slot Misalignment Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0285-2025 (September 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0285-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.