Z-0371-2014Class II

Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm...

Name: Z-0371-2014 Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm...
Creator: Ergosafe Products LLC DBA Prism Medical Services USA
Published: 2013-10-30
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2013-10-30 / Terminated / root cause: design

FDA source

Ergosafe Products LLC DBA Prism Medical Services USA began a recall of Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare... on 2013-10-30. FDA classified it as Class II and gives the reason as "The lift might fail with the labeled 500-lb. load rating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0371-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Posted: 2013-11-20
Terminated: 2017-05-17
Recalling firm: Handicare USA, Inc.
Product: Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: The lift might fail with the labeled 500-lb. load rating.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Medcare Products, sent an "URGENT FIELD CORRECTIVE ACTIONS" letter dated October 21, 2013 via certified mail on October 30, 2013 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to peel off the boom stickers and serial number label and replace with the new ones supplied; review the revised Manual and dispose of the original; and complete the action report form once the products have been relabeled. Please refer to your Operations Manual or visit our website at www.medcarelifts.com to view the manual online. If we can answer any questions that you may have regarding the testing standards or the relabeling of the products, please do not hesitate to contact us at 1-800-695-4479.
Quantity in commerce: 233 units
Distribution: Nationwide distribution.
Product codes and lots: Serial numbers 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070, 0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150, 0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035, 0308SWH0046, 0308SWH0047, 0309SWH0080, 0309SWH0081, 0309SWH0082, 0311SWH0157, 0311SWH0158, 0312SWH0211, 0312SWH0212, 0312SWH0213, 0312SWH0214, 0313SWH0234, 0313SWH0235, 0313SWH0236, 0408SWH0048, 0409SWH0083, 0409SWH0084, 0409SWH0085, 0409SWH0086, 0409SWH0087, 0409SWH0088, 0409SWH0089, 0409SWH0090, 0409SWH0091, 0409SWH0092, 0409SWH0093, 0409SWH0094, 0409SWH0095, 0409SWH0096, 0409SWH0097, 0409SWH0098, 0409SWH0099, 0411SWH0159, 0411SWH0161, 0412SWH0215, 0412SWH0216, 0507SWH0036, 0507SWH0037, 0507SWH0038, 0507SWH0039, 0508SWH0050, 0510SWH0118, 0510SWH0119, 0510SWH0120, 0510SWH0121, 0511SWH0162, 0511SWH0163, 0511SWH0164, 0512SWH0217, 0512SWH0218, 0512SWH0219, 0512SWH0220, 0512SWH0221, 0512SWH0222, 0613SWH0237, 0613SWH0238, 0613SWH0239, 0613SWH0240, 0613SWH0241, 0613SWH0242, 0613SWH0243, 0613SWH0244, 0613SWH0245, 0613SWH0246, 0613SWH0247, 0613SWH0248, 0613SWH0249, 0613SWH0250, 0708SWH0052, 0708SWH0053, 0709SWH0100, 0710SWH0122, 0710SWH0123, 0711SWH0165, 0711SWH0166, 0711SWH0167, 0711SWH0168, 0711SWH0169, 0711SWH0170, 0712SWH0223, 0712SWH0224, 0712SWH0225, 0805SWH0001, 0805SWH0002, 0805SWH0003, 0805SWH0004, 0806SWH0013, 0806SWH0014, 0806SWH0015, 0806SWH0016, 0808SWH0054, 0808SWH0055, 0808SWH0056, 0809SWH0101, 0810SWH0124, 0810SWH0125, 0810SWH0126, 0810SWH0127, 0812SWH0226, 0812SWH0227, 0812SWH0228, 0906SWH0017, 0907SWH0040, 0908SWH0057, 0908SWH0058, 0908SWH0059, 0908SWH0060, 0908SWH0061, 0908SWH0062, 0910SWH0128, 0910SWH0129, 0910SWH0130, 0910SWH0131, 0910SWH0132, 0910SWH0133, 0910SWH0134, 0910SWH0135, 0910SWH0136, 0910SWH0137, 0910SWH0138, 0910SWH0139, 0911SWH0171, 0911SWH0172, 0911SWH0173, 0911SWH0174, 0911SWH0175, 0911SWH0176, 0911SWH0177, 0911SWH0178, 0911SWH0179, 0911SWH0180, 0911SWH0181, 0911SWH0182, 0911SWH0183, 0911SWH0184, 1006SWH0018, 1006SWH0019, 1006SWH0020, 1006SWH0021, 1006SWH0022, 1006SWH0023, 1006SWH0024, 1007SWH0041, 1007SWH0042, 1007SWH0043, 1009SWH0102, 1009SWH0103, 1009SWH0104, 1009SWH0105, 1009SWH0106, 1009SWH0107, 1009SWH0108, 1009SWH0109, 1009SWH0110, 1009SWH0111, 1009SWH0112, 1009SWH0113, 1009SWH0114, 1011SWH0185, 1012SWH0229, 1012SWH0230, 1012SWH0231, 1012SWH0232, 1106SWH0025, 1106SWH0026, 1106SWH0027, 1106SWH0028, 1106SWH0029, 1106SWH0030, 1108SWH0063, 1108SWH0064, 1109SWH0115, 1110SWH0140, 1110SWH0141, 1111SWH0195, 1205SWH0005, 1205SWH0006, 1205SWH0007, 1209SWH0116, 1209SWH0117, 1210SWH0142, 1210SWH0144, 1210SWH0145, 1210SWH0146, and 1210SWH0147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0371-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0370-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20
Z-0371-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20

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)