Z-1778-2019Class II

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003

Name: Z-1778-2019 Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-05-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-05-20 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in... on 2019-05-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1778-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-20
Posted: 2019-06-13
Terminated: 2023-12-15
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: MEC Disinfector, Medical Devices
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Getinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle. Contact a Getinge Service person if either of these are noticed: o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to Friday
Quantity in commerce: 40 units
Distribution: Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Product codes and lots: Serail Numbers: WAA088623 WAA088625 WAA088637 WAA088639 WAA088686 WAA088775 WAA088776 WAA088777 WAA088819 WAA088825 WAA088866 WAA088894 WAA088917 WAA088948 WAA088949 WAA088950 WAA088951 WAA089058 WAA089060 WAA089123 WAA089137 WAA089138 WAA089141 WAA089143 WAA089201 WAA089247 WAA089251 WAA089262 WAA089269 WAA089295 WAA089298 WAA089323 WAA089327 WAA089334 WAA089337 WAA089350 WAA089363 WAA089416 WAA089436 WAA089649

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1778-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1777-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13
Z-1778-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)