Ergosafe Products LLC DBA Prism Medical Services USA: 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.

Recall number

Z-0371-2014

Recalling firm

Ergosafe Products LLC DBA Prism Medical Services USA

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.

Status

Terminated

Initiated

2013-10-30

Posted

2013-11-20

Terminated

2017-05-17

Reason

The lift might fail with the labeled 500-lb. load rating.

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

233 units

Distribution

Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSA

Firm FEI

3007802293

Firm city

Maryland Heights

Firm state

MO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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