Z-1205-2023Class II

Sit to Stand STS500 Patient Lift

Name: Z-1205-2023 Sit to Stand STS500 Patient Lift
Creator: Med-Mizer, Inc.
Published: 2023-02-03
License: https://open.fda.gov/license/

Med-Mizer, Inc. / initiated 2023-02-03 / Open, Classified / root cause: design

FDA source

Med-Mizer, Inc. began a recall of Sit to Stand STS500 Patient Lift on 2023-02-03. FDA classified it as Class II and gives the reason as "Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1205-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-03
Posted: 2023-03-02
Recalling firm: Med-Mizer, Inc.
Product: Sit to Stand STS500 Patient Lift
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.
Root cause tag: design
FDA root cause: Device Design
Action: Med-Mizer notified distributors of this recall event by distributing an Urgent Medical Device Recall Notice on 02/03/2022 via Certified Mail. The MR600 and STS500 Patient Lifts are being subject to recall due to the potential for the nut securing the boom to become loose over time, which could result in the boom moving unexpectedly side to side or dropping the patient during operation. Customers are asked to inspect all affected devices at their facility to determine if the nut securing the boom is loose. If it is, immediately remove the device from service. Med-Mizer is providing customers with affected devices replacement parts in order to complete the correction. Customers are to complete the provided Correction Response Form to Med-Mizer and return via fax at (812)932-5678, by email at [email protected], or by mail at 80 Commerce Drive, Batesville, IN 47006. If your firm is a distributor, please provide this notice to your customers. Any questions can be directed to Med-Mizer by phone at (877)867-7365.
Quantity in commerce: 37 units
Distribution: Awaiting consignee list from the recalling firm.
Product codes and lots: UDI-DI: 00852195007353; Serial No.: STS500000, STS500001, STS500002, STS500003, STS500004, STS500005, STS500006, STS500007, STS500008, STS500009, STS500010, STS500011, STS500012, STS500013, STS500014, STS500015, STS500016, STS500017, STS500018, STS500019, STS500020, STS500021, STS500022, STS500023, STS500024, STS500025, STS500026, STS500027, STS500028, STS500029, STS500030, STS500031, STS500032, STS500033, STS500034, STS500035, and STS500036.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1205-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-02
Z-1205-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-02

Product code FSA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)