Recall Register

Food, drugs, devices › Invacare Corporation

Device recall: Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

FDA enforcement event 65348 · Class II · initiated 4 Jun 2013 · status Terminated · terminated 4 Jan 2016

DeviceVoluntary: Firm initiated1 product recordElyria, OH

FDA enforcement event 65348 is a device recall by Invacare Corporation of Elyria, OH, initiated 4 Jun 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 4 Jan 2016. Initiation: voluntary: firm initiated. Invacare Corporation has 26 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Invacare Corporation, Elyria, OH.

Reason for recall

"Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks."

Distribution

"Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…"

Product records

Recall numberProductQuantityClassStatusReport date
Z-2270-2013Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.166,230Class IITerminated2 Oct 2013

Context

90%of 2013 device events are Class II1,236 events that year
1product record in this eventfirm median: 1
26events on this register for the firm

Other enforcement events for Invacare Corporation

InitiatedProduct (first record)TypeClassRecords
22 Jan 2024Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) DeviceClass II1
15 Jun 2023DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654DeviceClass II1
10 Jun 2022Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)DeviceClass III1
30 Mar 2022Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2VDeviceClass II1
12 Nov 2021Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) ModDeviceClass II3
30 Oct 2020Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygenDeviceClass II1
16 Nov 2018Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient DeviceClass II1
25 Apr 2017Assist Bed Rail - 6632DeviceClass II1
2 Dec 2016Bariatric Bed - BAR600IVCDeviceClass II4
21 Jun 2016lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric DeviceClass II2

All 26 events for Invacare Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Jan 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.