Data Foundry

Medical device recalls 2019

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003… — Class II medical device recall Z-1778-2019

Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2019-06-19, distributed nationwide. Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse d

Recall numberZ-1778-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMaquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States
Recall initiated2019-05-20
Classified2019-06-13
Reported by FDA2019-06-19
Terminated2023-12-15
DistributedNationwide (US)
Countries outside the USAE, AU, CA, CH, CN, DE, FR, IN, JP, KR, NL, SA, SE, TH, TR, UA, ZA
Quantity40 units
Model numbersS-86682003

Product

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Reason for recall

Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

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-1778-2019. 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.