Invacare Corporation: Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.

Recall number

Z-0774-2012

Recalling firm

Invacare Corporation

Product

Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.

Status

Terminated

Initiated

2011-12-07

Posted

2012-01-17

Terminated

2013-07-02

Reason

Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.

Root cause

Device Design

Action

On 12/7/2011 the firm sent Urgent: Recall Information Letters to their customers. The letter informed customers of the affected product and the related problem. The letter also states that Invacare has developed replacement seat kits intended to replace the original seats. The replacement kit will be provided free of charge and can be ordered by completing and returning the attached response card. After receiving replacement kits, customers are asked to contact their customers that have potentially affected devices and replace the seats immediately. Questions should be directed to Customer Service at 1-800-333-6900.

Quantity

391 scooters

Distribution

Worldwide Distribution -- USA, including the states of AK, CA, FL, GA, HI, IA, ID, IL, KS, LA, MD, MI, MN, MO, MT, NC, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, & WI, and the countries of AUSTRIA, BELGIUM, CZECH REPUBLIC, ESTONIA, FRANCE, GERMANY, IRELAND, ITALY, JERSEY (CHANNEL ISLANDS), LITHUANIA, PORTUGAL, SWEDEN, SWITZERLAND, & UNITED KINGDOM.

Lot, serial or model codes

Model # LEO-4B; Serial # 10MCT000110, 10MCT000111, 10MCT000112, 10MCT000113, 10MCT000114, 10MCT000115, 10MCT000116, 10MCT000117, 10MCT000118, 10MCT000119, 10MCT000120, 10MCT000121, 10MCT000122, 10MCT000123, 10MCT000124, 10MCT000125, 10MCT000126, 10MCT000127, 10MCT000128, 10MCT000129, 10MCT000130, 10MCT000131, 10MCT000132, 10MCT000133, 10MCT000134, 10MCT000135, 10MCT000136, 10MCT000137, 10MCT000138, 10MCT000139, 10MCT000140, 10MCT000141, 10MCT000142, 10MCT000143, 10MCT000144, 10MCT000145, 10MCT000146, 10MCT000147, 10MCT000148, 10MCT000149, 10MCT000150, 10MCT000151, 10MCT000152, 10MCT000153, 10MCT000154, 10MCT000155 & 10MCT000156. Model # LEO-4S; Serial # 10MCT000001, 10MCT000002, 10MCT000003, 10MCT000004, 10MCT000005, 10MCT000006, 10MCT000007, 10MCT000008, 10MCT000009, 10MCT000010, 10MCT000011, 10MCT000012, 10MCT000013, 10MCT000014, 10MCT000015, 10MCT000016, 10MCT000017, 10MCT000018, 10MCT000019, 10MCT000020, 10MCT000021, 10MCT000022, 10MCT000023, 10MCT000024, 10MCT000025, 10MCT000026, 10MCT000027, 10MCT000028, 10MCT000029, 10MCT000030, 10MCT000031, 10MCT000032, 10MCT000033, 10MCT000034, 10MCT000035, 10MCT000036, 10MCT000037, 10MCT000038, 10MCT000039, 10MCT000040, 10MCT000041, 10MCT000042, 10MCT000043, 10MCT000044, 10MCT000045, 10MCT000046, 10MCT000047, 10MCT000048, 10MCT000049, 10MCT000050, 10MCT000051, 10MCT000052, 10MCT000053, 10MCT000054, 10MCT000055, 10MCT000056, 10MCT000057, 10MCT000058, 10MCT000059, 10MCT000060, 10MCT000061, 10MCT000062, 10MCT000063, 10MCT000064, 10MCT000065, 10MCT000066, 10MCT000067, 10MCT000068, 10MCT000069, 10MCT000070, 10MCT000071, 10MCT000072, 10MCT000073, 10MCT000074, 10MCT000075, 10MCT000076, 10MCT000077, 10MCT000078, 10MCT000079, 10MCT000080, 10MCT000081, 10MCT000082, 10MCT000083, 10MCT000084, 10MCT000085, 10MCT000086, 10MCT000087, 10MCT000088, 10MCT000089, 10MCT000090, 10MCT000091, 10MCT000092, 10MCT000093, 10MCT000094, 10MCT000095, 10MCT000096, 10MCT000097, 10MCT000098, 10MCT000099, 10MCT000100, 10MCT000101, 10MCT000102, 10MCT000103, 10MCT000104, 10MCT000105, 10MCT000106, 10MCT000107, 10MCT000108, 10MCT000109, 10MDG0001, 10MDG0002, 10MDG0003, 10MDG0004, 10MDG0005, 10MDG0006, 10MDG0007, 10MDG0008, 10MDG0009, 10MDG0010, 10MDG0011, 10MDG0012, 10MDG0013, 10MDG0014, 10MDG0015, 10MDG0016, 10MDG0017, 10MDG0018, 10MDG0019, 10MDG0020, 10MDG0021, 10MDG0022, 10MDG0023, 10MDG0024, 10MDG0025, 10MDG0026, 10MDG0027, 10MDG0028, 10MDG0029, 10MDG0030, 10MDG0047, 10MDG0048, 10MDG0049, 10MDG0050, 10MDG0051, 10MDG0052, 10MDG0053, 10MDG0054, 10MDG0055, 10MDG0056, 10MDG0057, 10MDG0058, 10MDG0059, 10MDG0060, 10MDG0061, 10MDG0062, 10MDG0063, 10MDG0064, 10MDG0065, 10MDG0066, 10MDG0067, 10MDG0068, 10MDG0069, 10MDG0070, 10MDG0071, 10MDG0072, 10MDG0073, 10MDG0074, 10MDG0075, 10MDG0076, 10MDG0077, 10MDG0078, 10MDG0079, 10MDG0080, 10MDG0081, 10MDG0082, 10MDG0083, 10MDG0084, 10MDG0085, 10MDG0086, 10MDG0087, 10MDG0088, 10MDG0089, 10MDG0090, 10MDG0091, 10MDG0092, 10MDG0093, 10MDG0094, 10MDG0095, 10MDG0096, 10MDG0097, 10MDG0098, 10MDG0099, 10MDG0100, 10MDG0101, 10MDG0102, 10MDG0103, 10MDG0104, 10MDG0105, 10MDG0106, 10MDG0107, 10MDG0108, 10MDG0109, 10MDG0110, 10MDG0111, 10MDG0112, 10MDG0113, 10MDG0114, 10MDG0115, 10MDG0116, 10MDG0117, 10MDG0118, 10MDG0119, 10MDG0120, 10MDG0121, 10MDG0122, 10MDG0123, 10MDG0124, 10MDG0125, 10MDG0126, 10MDG0127, 10MDG0128, 10MDG0129, 10MDG0130, 10MDG0131, 10MDG0132, 10MDG0133, 10MDG0134, 10MDG0135, 10MDG0151, 10MDG0152, 10MDG0153, 10MDG0154, 10MDG0155, 10MDG0156, 10MDG0157, 10MDG0158, 10MDG0159, 10MDG0160, 10MDG0161, 10MDG0162, 10MDG0163, 10MDG0164, 10MDG0165, 10MDG0166, 10MDG0167, 10MDG0168, 10MDG0169, 10MDG0170, 10MDG0171, 11ADG0001, 11ADG0002, 11ADG0003, 11ADG0004, 11ADG0005, 11ADG0006, 11ADG0007, 11ADG0008, 11ADG0009, 11ADG0010, 11ADG0011, 11ADG0012, 11ADG0013, 11ADG0014, 11ADG0015, 11ADG0016, 11ADG0017, 11ADG0018, 11ADG0019, 11ADG0020, 11ADG0021, 11ADG0022, 11ADG0023, 11ADG0024, 11ADG0025, 11ADG0026, 11ADG0027, 11ADG0028, 11ADG0029, 11ADG0030, 11ADG0031, 11ADG0032, 11ADG0033, 11ADG0034, 11ADG0035, 11ADG0036, 11ADG0037, 11ADG0038, 11ADG0039, 11ADG0040, 11ADG0041, 11ADG0042, 11ADG0073, 11ADG0074, 11ADG0075, 11ADG0076, 11ADG0077, 11ADG0078, 11ADG0079, 11ADG0080, 11ADG0081, 11ADG0082, 11ADG0083, 11ADG0084, 11ADG0085, 11ADG0086, 11ADG0087, 11ADG0088, 11ADG0089, 11ADG0090, 11ADG0091, 11ADG0092, 11ADG0093, 11ADG0094, 11ADG0095, 11ADG0096, 11ADG0097, 11ADG0098, 11ADG0099, 11ADG0100, 11ADG0101, 11ADG0102, 11ADG0103, 11ADG0104, 11ADG0105, 11ADG0106, 11ADG0107, 11ADG0108, 11ADG0109, 11ADG0110, 11ADG0111, 11ADG0112, 11ADG0113, 11ADG0114, 11ADG0115, 11ADG0116, 11ADG0117, 11ADG0118, 11ADG0119, 11ADG0120, 11ADG0121, 11ADG0122, 11ADG0123, 11ADG0124, 11ADG0125, 11ADG0126, 11ADG0127, 11ADG0128, 11ADG0129, 11ADG0130, 11ADG0131, 11ADG0132, 11ADG0133, 11ADG0134, 11ADG0135, 11ADG0136, 11ADG0137, 11ADG0138, 11ADG0139, 11ADG0140, 11ADG0141 & 11ADG0142.

510(k) numbers

["K090735"]

PMA numbers

not on file

Product code

INI

Firm FEI

3002889431

Firm city

Elyria

Firm state

OH

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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