Data Foundry

Medical device recalls 2025

Brand Name: Branding is not applied to this product — Class II medical device recall Z-0168-2026

Ongoing recall by Spacelabs Healthcare, Inc., reported 2025-10-22, distributed nationwide. Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequa

Recall numberZ-0168-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Inc., Snoqualmie, WA, United States
Recall initiated2025-09-05
Classified2025-10-16
Reported by FDA2025-10-22
DistributedNationwide (US)
Quantity820
UPC / GTIN / UDI-DI10841522131455, 10841522131479
Model numbers012-0895-12

Product

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Reason for recall

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0168-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.