Z-1505-2021Class II

Scooter

Name: Z-1505-2021 Scooter
Creator: Merits Holdings Co. dba Merits Health Products, Inc.
Published: 2021-04-01
License: https://open.fda.gov/license/

Merits Health Products, Inc. / initiated 2021-04-01 / Open, Classified

FDA source

Merits Holdings Co. dba Merits Health Products, Inc. began a recall of Scooter on 2021-04-01. FDA classified it as Class II and gives the reason as "Seat baseplate pin has broken in the field". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1505-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-01
Posted: 2021-04-28
Recalling firm: Merits Health Products, Inc.
Product: Scooter
Product code: INI Vehicle, Motorized 3-Wheeled
Reason for recall: Seat baseplate pin has broken in the field.
FDA root cause: Process change control
Action: A Recall notification letter titled, "MEDICAL DEVICE FIELD CORRECTION" was sent to consignees on 04/07/2021 via email and by certified mail on 04/16/2021. The firm stated they made phone call notifications on 04/01/2021. The letter instructs the consignee to Contact impacted customer using a personalized customer letter (template provided). The notification can be sent by mail, email or phone. (IF by phone, please keep a log of call. Date/Time/Result); replace the old seat plate with new one provided using the SOP provided. The field correction should take approximately 15 minutes to complete.; complete and return the Service and Repair Report (sent with new part), inspect the installation and note it on the appropriate Scooter or Power Chair Inspection Record provided; use the RA shipping label (sent with new part) and return old seat plate to Merits Health Products along with the Service and Repair Report (one filled out for each unit); and when all of the units in the possession of the consignee are finished, please return the completed Inspection Report/s to Merits by mail or email.
Quantity in commerce: 189 units
Distribution: Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada
Product codes and lots: Pioneer 3 Scooter - Model Number: S131; Part No: S13152ARMU; Serial Numbers: MU200900928, MU200600612, MU200600610, MU200600887, MU200600621, MU200600620, MU200600619, MU200600618, MU200600608, MU200600616, MU200600609, MU200600607, MU200600615, MU200600613, MU200900930, MU200600892, MU200600874, MU200600889, MU200600877, MU200600617, MU200600888, MU200600876, MU200600883, MU200600879, MU200600885, MU200900923, MU200600886, MU200600893, MU200600890, MU200600611, MU200600875 Pioneer 3 Scooter - Model Number: S131; Part No: S13152SBMU; Serial Numbers: MU200900944, MU200900942 Pioneer 4 Scooter - Model Number: S141; Part No: S14151ARMU; Serial Numbers: MU200900956, MU200900953 Pioneer 4 Scooter - Model Number: S141; Part No: S14152ARMU; Serial Numbers: MU200800943, MU200600346, MU200600353, MU200600357, MU200800940, MU200900961, MU200801127, MU200801132, MU200800947, MU200600360, MU200800938, MU200801131, MU200600358, MU200600359, MU200600344, MU200801134, MU200600354, MU200600356, MU200600351, MU200600345, MU200600355, MU200600348, MU200801122, MU200801128, MU200900971, MU200600347, MU200600361, MU200600352, MU200600349, MU200600350, MU200800931, MU200800951, MU200800949, MU200801121, MU200800941, MU200800939, MU200800942, MU200801133, MU200801125, MU200900970, MU200801123 Pioneer 4 Scooter - Model Number: S141; Part No: S14152SBMU; Serial Numbers: MU200800952, MU200501029, MU200500382, MU200501033, MU200500381, MU200501039, MU200500363, MU200500359, MU200801161, MU200500372, MU200801157, MU200501031, MU200500364, MU200501044, MU200501042, MU200800962, MU200500378, MU200601118, MU200601123, MU200601112, MU200601110, MU200601111, MU200800957, MU200801152, MU200800976, MU200601114, MU200601121, MU200601126, MU200800975, MU200801168, MU200901022, MU200501032, MU200501046, MU200901029, MU200901020, MU200500376, MU200501028, MU200501036, MU200501041, MU200501037, MU200501040, MU200601125, MU200601120, MU200501047, MU200501038, MU200501043, MU200501034, MU200501035, MU200501030, MU200601116, MU200601117, MU200601115, MU200901004, MU200901023, MU200901007, MU200901014, MU200901008, MU200901016, MU200901000, MU200601113, MU200500365, MU200500373, MU200500371, MU200500361, MU200500374, MU200500367, MU200800973, MU200500360 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-ARMUB; Serial Numbers: MU200600053, MU200600052, MU200600051, MU200600054 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-SBMUB; Serial Numbers: MU200600056, MU200600058, MU200600059 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-ARMUB; Serial Numbers: MU200400958, MU200400969, MU200601135, MU200400960, MU200400967, MU200400968, MU200400965, MU200400964, MU200400966, MU200400962, MU200400963 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-SBMUB; Serial Numbers: MU200400975, MU200400988, MU200400979 Pioneer 9 Scooter - Model Number: S331; Part No: S331-1ARMU; Serial Numbers: MU200801178, MU200700070, MU200700075, MU200700076, MU200700069, MU200801188 Pioneer 10 Scooter - Model Number: S341; Part No: S341-1ARMU; Serial Numbers: MU200800993, MU200800992, MU200800991, MU200800994, MU200800979, MU200800977, MU200800983, MU200800989, MU200800995, MU200800990 Silverado Extreme Scooter - Model Number: S940; Part No: S940A-SDMU; Serial Numbers: MU200800528, MU200700079, MU200800531, MU200800526, MU200800535, MU200700085, MU200700081 Silverado Scooter - Model Number: S941; Part No: S941A1SVMU; Serial Numbers: MU200800538

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1505-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1504-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-27
Z-1505-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-27

Product code INI

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)