Coverage explainer
Mobility Equipment Recalls: The Tracker
How FDA and CPSC recalls work for wheelchairs, lifts, beds, rollators and scooters, where to check, and a sourced list of 2025 and 2026 mobility recalls.
Mobility equipment recalls split between two agencies: FDA handles medical devices (wheelchairs, power wheelchairs, patient lifts, hospital and homecare beds, CPAP machines) and CPSC handles consumer products (adult portable bed rails, recreational e-scooters, infant walkers). The list at the bottom of this page covers every 2025 and 2026 mobility recall we could verify from FDA and CPSC records, and it is updated as the digest covers new ones.
How a medical device recall works (FDA)
FDA regulation 21 CFR 7.3 defines a recall as “a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers.” A correction means repair, modification, adjustment, relabeling, destruction or inspection without moving the product; a removal means physically taking it back. A market withdrawal, by contrast, fixes a minor problem that would not draw FDA legal action, and it is not a recall.
Almost all device recalls are voluntary. FDA’s postmarket page says manufacturers conduct them under 21 CFR Part 7, and only “in rare instances” does FDA order a recall under 21 CFR Part 810 and section 518(e) of the Food, Drug, and Cosmetic Act. The reporting duty sits in 21 CFR Part 806: a manufacturer or importer must report any correction or removal undertaken to reduce a risk to health, or to remedy a violation that may present a risk to health, within 10 working days of starting it (21 CFR 806.10(b)).
FDA then assigns a class under 21 CFR 7.3(m):
- Class I: a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.
- Class II: use may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote.
- Class III: use is not likely to cause adverse health consequences.
Classified recalls enter the Medical Device Recalls database, which holds recalls classified since November 2002 and, since January 2017, may also include corrections or removals a firm started before FDA review. FDA separately posts the most serious actions and early alerts on its Medical Device Recalls and Early Alerts page. An early alert is a notice about a potentially high-risk issue posted while FDA is still collecting information; a September 29, 2025 update on that page says CDRH expanded the communications pilot to all medical devices.
How a consumer product recall works (CPSC)
CPSC’s duty-to-report page says manufacturers, importers, distributors and retailers must report a product that has a defect that could create a substantial risk of injury, that creates an unreasonable risk of serious injury or death, or that fails to comply with a consumer product safety rule. The report is due “within 24 hours of obtaining reportable information,” the firm’s investigation “should not exceed 10 working days,” and injury does not have to have occurred. Reports are filed through SaferProducts.gov. Filing does not automatically trigger a recall; CPSC staff evaluate the report and work with the firm on corrective action.
CPSC’s recall listings carry the hazard, the remedy, the number of units and consumer contact details; product safety warnings appear in the same feed with a consumer action instead of a remedy. Adult portable bed rails fall under a mandatory CPSC standard, which is why nearly every 2025 to 2026 bed rail recall cites a violation of it.
Where to check
- FDA Medical Device Recalls database: accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm. Search by product name, product code, recall class, firm, date range or recall number. Page last updated October 29, 2026.
- FDA Medical Device Recalls and Early Alerts: fda.gov/medical-devices/medical-device-safety/medical-device-recalls-and-early-alerts. The most serious recalls plus early alerts, with a free email subscription.
- openFDA device enforcement API: open.fda.gov/apis/device/enforcement. JSON from FDA’s Recall Enterprise System, 2004 to present, updated weekly. We query
api.fda.gov/device/enforcement.jsonbyproduct_descriptionandrecall_initiation_date. - CPSC recall search: cpsc.gov/Recalls. Filter by date, hazard and category, export CSV, or subscribe to recall emails. CPSC says the download data updates weekly.
- CPSC Recall API: saferproducts.gov/RestWebServices/Recall. XML by default; add
format=jsonfor JSON. - Report a problem: SaferProducts.gov for consumer products, FDA MedWatch for medical devices.
How to register and stay notified
Recall notices identify products by model, lot or serial number, and manufacturers reach users through their customer records: Permobil mailed its recall letter on August 12, 2025, and Baxter sent separate letters to facilities (May 30, 2025) and home patients (June 2, 2025). A user who bought through a dealer may not be on that list, so keep the purchase record and serial number, register the product with the manufacturer where offered, and subscribe to the FDA and CPSC email alerts linked above.
What a supplier must do
The manufacturer’s notice sets the supplier’s tasks. Permobil told distributors to pull all SpeedControl Dials from sellable inventory, carry the recall to the end-user level, and either notify end users with a copy of the notice or hand end-user contact details to Permobil through its portal. Baxter asked consignees to post its letter where affected lifts are stored or used. Under CPSC rules, distributors and retailers share the 24-hour duty to report; under FDA rules the Part 806 report belongs to the manufacturer or importer.
Recent mobility recalls
Dates are the FDA posting date or the recall initiation date as noted; units come from FDA enforcement records or CPSC notices. Only recalls with an opened source are listed.
Beds and bed rails
- October 29, 2026 (early alert). All Medline brand beds and accessories (homecare, bariatric and long-term care beds, pendants, accessories, replacement parts). Firm: Medline Industries, LP. Reason: potential fire hazard; under conditions such as excessive loading, jammed motors, fluid in the pendant or use of extension cords or non-Medline accessories, electrical components may overheat and progress to smoking, melting or fire. Remedy: Medline announced a market exit on October 14, 2026 and on October 24, 2026 set up repair for certain beds and replacement or full or partial refund for others purchased in the last five years; users should keep beds unplugged except while repositioning. Status: early alert, FDA still reviewing. Source.
- February 13, 2026 (FDA posting; initiated November 26, 2025). Medline Basic and Medlite homecare beds, items MDR107002E, MDR107002E-4, MDR107003E, MDR107003E-4, MDR107003ELO, MDR107002L, MDR107003L, MDR107003LO. Class I correction, about 599,000 units across six enforcement records (Z-1011-2026 through Z-1016-2026). Reason: hand control pendants overheating, sparking and catching fire; 12 injuries and one death reported as of December 18, 2025, plus two injuries and one death from entrapment with non-Medline accessories. Remedy: updated use instructions, including leaving the bed unplugged unless adjusting it and using only Medline rails and accessories. Source.
- March 26, 2026. Vive Health adult portable bed rails (models LVA2009SLV, LVA2097SLV and LVA1024 bought on or before August 21, 2023), about 122,000 units, CPSC recall 26-341. Importer: Vive Health LLC, Naples, Florida; manufacturer Ningbo Shenyu Medical Equipment Co., China. Reason: entrapment between rail and mattress; two deaths reported in September 2024 (a 97-year-old man in Texas and a 93-year-old man in Florida). Remedy: full refund after marking the rail “RECALLED” and emailing a photo. A February 19, 2026 Vive Health recall covered 12,355 later-production LVA1024 rails. Source.
- May 2025 through October 2026. At least 31 adult portable bed rail recalls appear in the CPSC API for this period, nearly all for violating the mandatory standard (entrapment and asphyxiation risk) with a full refund remedy. The larger ones: WeHwupe (about 94,800 units, May 29, 2025), KingPavonini (about 81,050, November 26, 2025), Sangohe expanded (about 36,500, April 2, 2026), Agrish expanded (about 35,083, October 1, 2026), Easymake (about 19,000, April 9, 2026) and ZOLIQUEX (about 16,000, April 16, 2026). Source.
Power wheelchairs and power assist
- June 25, 2026 (initiated). Quantum Rehab power wheelchairs with controller software 2.0.11 (Q6 Edge 2.0, Q6 Edge 2.0 iLevel, Q6 Edge 3, Q6 Edge 3 Stretto, Q6 Edge 4, Q6 Edge HD, 4Front, 4Front 2, 4Front 2HD, Quantum 1450, Outback, Rival, R-TRAK). Firm: Pride Mobility Products Corp., Duryea, Pennsylvania. Class II, records Z-2841-2026 through Z-2853-2026, classified July 31, 2026. Reason: if “Remind Me Later” is selected, reminder pop-ups can appear while driving and trigger an unexpected park brake stop. Remedy: software update to version 2.0.13. Source.
- June 19, 2026 (initiated). munevo DRIVE and munevo DRIVE r-net head control for power wheelchairs. Firm: munevo GmbH. Class II (Z-2856-2026), 19 units. Reason: a software issue can push the drive out of calibration, causing steering drift. Source.
- December 29, 2025 (initiated). WHILL Model C2 (software before HMI 2.22 / MC 1.13) and Model F (before HMI 2.23 / MC 1.05) power wheelchairs. Firm: WHILL, Inc. Class I, Z-1826-2026 and Z-1827-2026, classified April 24, 2026; 4,685 and 2,324 units. Reason: a Bluetooth (BLE) cyber vulnerability identified through the CISA vulnerability disclosure program. Remedy: software update to the listed versions. Source.
- November 25, 2025 (FDA posting; initiated August 12, 2025). All SpeedControl Dials (MX2-3DCK, MX2-3DC, MX2-3DCMC) for the SmartDrive MX2+ power assist device, including dials replaced in the earlier February 2025 recall. Firm: Max Mobility/Permobil. Class I, records Z-2538, Z-2539 and Z-2540-2025, about 49,600 units. Reason: an intermittent electrical connection can make the power assist fail to stop or move involuntarily; two serious injuries reported as of July 29, 2025. Remedy: stop using the dial and use a wired SwitchControl or the wearable app; Permobil replaces dials with a SwitchControl. Source.
- September 16, 2025 (FDA posting; initiated July 10, 2025). mo-Vis R-net joysticks (Micro, Multi, All-round, IDM-MICRO-R, IDM-MULTI-R, IDM-ARLITE-R) with firmware 2.3 or lower. Firm: mo-Vis BVBA, Belgium. Class I correction. Reason: a firmware error can skip the neutral check and let the wheelchair move unexpectedly; one injury reported. Remedy: firmware update to version 2.6 at the next annual maintenance. Source.
- June 19, 2025 (initiated; reported retroactively). Permobil M5 Corpus power wheelchair, REF 120032. Firm: Permobil Inc., Lebanon, Tennessee. Class II (Z-2805-2026), classified July 24, 2026, 715 wheelchairs. Reason: power platform firmware missing drive inhibit logic, which may allow the chair to drive under restricted conditions. Source.
- April 24, 2025 (initiated). iBOT personal mobility device, software 01.05.24. Firm: Mobius Mobility LLC, Manchester, New Hampshire. Class II (Z-1965-2025), 442 units. Reason: a software issue could lead to tipping from Balance Mode. Source.
Patient lifts
- March 10, 2026 (initiated). Arjo Tenor mobile passive patient lift, models KHA1000 US and KHA1010 US. Firm: ArjoHuntleigh Polska. Class II (Z-1811-2026), 119 units. Reason: an actuator component in one production batch may lack required mechanical strength, risking uncontrolled downward movement of the lifting arm. Source.
- December 18, 2025 (initiated). Rifton Low Base TRAM powered transfer and gait-training lift, model K320. Firm: Community Products, LLC, Rifton, New York. Class II (Z-1138-2026), 1,096 units. Reason: potential fraying of the body support strap. Source.
- November 17, 2025 (initiated). Molift Mover 300 mobile hoist and Molift 2-point and 4-point sling bars. Firm: Etac A/S, Denmark. Class II (Z-1309, Z-1310 and Z-1311-2026), 71, 64 and 25 units. Reason: the bolt mounting the lifting bar broke during load testing; material deformation between the lifting bar and arm can limit joint movement. Source.
- July 23, 2025 (FDA posting; initiated May 30, 2025). Hillrom Q-Link 13 component (product code 3156509) used with Uno 102 EE, Viking L, XL, M, S and XS, and LikoLight mobile lifts, plus LikoScale adapter kits. Firm: Baxter Healthcare Corporation. Class I (Z-2031-2025), 9,899 units. Reason: false latching of the quick-release hook can let a sling bar detach and drop; three serious injuries and one death reported. Remedy: stop using Q-Link 13; Baxter supplies the replacement Q-link Mobile. Source.
Rollators and walkers
- August 14, 2026 (initiated). Medline bariatric basic steel rollators, blue (MDS86800XWBS) and burgundy. Firm: Medline Industries, LP. Class II (Z-0086-2027 and Z-0087-2027), classified October 5, 2026; 1,824 and 835 units. Reason: the front fork stem bolt and wheel assembly may disconnect from the frame, so front wheels can loosen or detach during use. Source.
Not found
Our openFDA queries for recalls initiated January 1, 2025 through October 30, 2026 returned no records with “crutch,” “knee scooter,” “scooter” or “stair lift” in the product description, and the CPSC API returned no wheelchair, rollator, adult walker, mobility scooter, knee scooter, stair lift or crutch recalls for the same period. CPSC’s scooter recalls in that window were kick and commuter e-scooters, such as the March 20, 2025 Segway Ninebot Max G30P and G30LP recall (about 220,000 units), not mobility devices.
What changed recently
- October 29, 2026. FDA posted an early alert covering all Medline brand beds and accessories after Medline’s October 14 market-exit notice and October 24 repair-or-refund update.
- October 5, 2026. FDA classified the Medline bariatric rollator recall as Class II (Z-0086-2027, Z-0087-2027).
- October 1, 2026. CPSC announced the expanded Agrish adult portable bed rail recall (about 35,083 units, up from about 5,000 in January 2026).
- July 31, 2026. FDA classified the Pride Mobility Quantum Rehab software recall as Class II.
- April 24, 2026. FDA classified the WHILL Model C2 and Model F Bluetooth vulnerability recall as Class I.
- March 26, 2026. CPSC announced the 122,000-unit Vive Health bed rail recall with two deaths reported.
- February 13, 2026. FDA posted the Medline homecare bed correction as a most-serious (Class I) recall.
- November 25, 2025. FDA posted Permobil’s expanded SpeedControl Dial recall covering all dials, including those replaced earlier in 2025.
This tracker is updated as the digest covers new mobility recalls. Readers who own an affected product should follow the remedy in the manufacturer’s notice and contact their supplier.
Questions people ask
Is a wheelchair recall handled by FDA or CPSC?
FDA. Wheelchairs, power wheelchairs, patient lifts, hospital beds and CPAP machines are regulated medical devices, so their recalls appear in the FDA Medical Device Recalls database and the weekly Enforcement Report. CPSC handles consumer products such as adult portable bed rails and recreational e-scooters.
What is the difference between a Class I and Class II recall?
Under 21 CFR 7.3, Class I means there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Class II means use may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. Class III means use is not likely to cause adverse health consequences.
How do I find out if my power wheelchair has been recalled?
Search the FDA Medical Device Recalls database by product name or manufacturer, check the FDA Medical Device Recalls and Early Alerts page for the most serious actions, and compare the serial or lot numbers in the notice with the label on your chair. Your supplier should also have received the manufacturer's recall letter.
What does a DME supplier have to do when a product is recalled?
Manufacturer notices seen in 2025 directed distributors to pull affected stock, notify end users with a copy of the notice, or hand end-user contact details to the manufacturer. Under CPSC law, distributors and retailers also carry a duty to report a defective product within 24 hours of obtaining reportable information.
Were any mobility scooters recalled in 2025 or 2026?
Our searches of the FDA enforcement data and the CPSC recall API on 2026-10-30 found none for mobility scooters (power operated vehicles). CPSC's scooter recalls in that period were kick scooters and commuter e-scooters, such as the March 2025 Segway Ninebot Max G30P recall.
What is an FDA early alert?
An early alert is a notice FDA posts about a potentially high-risk device issue while it is still collecting information and before it has classified the action. The October 29, 2026 Medline beds notice is an example; FDA says it will update the page as significant new information becomes available.
Sources
- 21 CFR 7.3 Definitions (recall, correction, market withdrawal, recall classification), eCFR, Oct 28, 2026
- 21 CFR 806.10 Reports of corrections and removals, eCFR, Oct 28, 2026
- Recalls, Corrections and Removals (Devices), FDA
- Medical Device Recalls and Early Alerts, FDA
- Medical Device Recalls database, FDA, Oct 29, 2026
- openFDA Device Recall Enforcement Reports API, FDA
- openFDA device enforcement query used for this page (recall_initiation_date 2025-01-01 to 2026-10-30), FDA, Oct 30, 2026
- Early Alert: Medline Removes or Corrects All Medline Brand Beds and Accessories, FDA, Oct 29, 2026
- Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds, FDA, Feb 13, 2026
- Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices, FDA, Nov 25, 2025
- Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error, FDA, Sep 16, 2025
- Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment, FDA, Jul 23, 2025
- Recalls and Product Safety Warnings, CPSC
- Duty to Report to the CPSC: Your Rights and Responsibilities, CPSC
- CPSC Recalls Application Program Interface (API) Information, CPSC
- CPSC Recall API query used for this page (bed rails, 2025-01-01 to 2026-10-30), CPSC, Oct 30, 2026
- Vive Health Recalls Adult Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Two Deaths Reported, CPSC, Mar 26, 2026
- Segway Recalls Segway Ninebot Max G30P and Max G30LP KickScooters Due to Fall Hazard, CPSC, Mar 20, 2025
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