Browse Device Recalls
37 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 37 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 37 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 22, 2024 | Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component... | Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to pre... | Class II | Invacare Corporation |
| Jun 15, 2023 | DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also ser... | Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the dev... | Class II | Invacare Corporation |
| Jun 10, 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... | Class III | Invacare Corporation |
| Mar 30, 2022 | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | The battery wiring harness on affected wheelchairs may become disconnected during shipment from t... | Class II | Invacare Corporation |
| Nov 12, 2021 | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Modul... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Nov 12, 2021 | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Nov 12, 2021 | Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Mod... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Oct 30, 2020 | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respirat... | Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization... | Class II | Invacare Corporation |
| Nov 16, 2018 | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P ... | Invacare has identified via customer complaints, the potential for the mounting bolt connecting t... | Class II | Invacare Corporation |
| Apr 25, 2017 | Assist Bed Rail - 6632 | A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could r... | Class II | Invacare Corporation |
| Dec 2, 2016 | Foot Section - BAR5490IVC | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Dec 2, 2016 | Bariatric Bed - BAR600IVC | The junction box used in the bariatric bed may emit sparks and result in a fire. | Class II | Invacare Corporation |
| Dec 2, 2016 | Junction Box - 1104343 and 1193560 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Dec 2, 2016 | Bariatric Bed - BARPKG-IVC 1633 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Jun 21, 2016 | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per... | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Invacare Corporation |
| Jun 21, 2016 | Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one ... | The rear gradation scale was screen printed upside down on the flowmeter gauge. | Class II | Invacare Corporation |
| Mar 15, 2016 | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is i... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usa... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Pro... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Feb 2, 2015 | Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp... | The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav... | Class II | Invacare Corporation |
| Jan 15, 2015 | Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Dec 5, 2014 | G- Series Beds; G29 full length bed rails assembly | Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of spe... | Class II | Invacare Corporation |
| Oct 31, 2014 | Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged on... | The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential ... | Class II | Invacare Corporation |
| Sep 23, 2014 | Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged ... | It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the siev... | Class II | Invacare Corporation |
| Jun 25, 2014 | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquat... | The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result... | Class II | Invacare Corporation |
| Jun 24, 2014 | MK5 NX Controller--Wheelchair controller | M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were ... | Class II | Invacare Corporation |
| Aug 31, 2013 | Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower ... | The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocea... | Class II | Invacare Corporation |
| Jun 18, 2013 | CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per ca... | There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord s... | Class II | Invacare Corporation |
| Jun 4, 2013 | Invacare Power Wheelchair, one per box To provide mobility to a person res... | Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended accelerat... | Class II | Invacare Corporation |
| Nov 6, 2012 | Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and ... | Following their receipt of several customer complaints, Invacare recalled their height adjustable... | Class II | Invacare Corporation |
| Sep 10, 2012 | Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to... | The potential exists for the wheel to rotate freely despite engagement of hub brake. | Class II | Invacare Corporation |
| Aug 6, 2012 | Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporati... | On August 6, 2012, Invacare voluntarily recalled the Invacare¿ I-Fit" Shower Chair (Models 9780, ... | Class II | Invacare Corporation |
| Apr 16, 2012 | Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs... | The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wh... | Class II | Invacare Corporation |
| Apr 6, 2012 | TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Mo... | Invacare Corporation decided to recall the product because of a potential risk of fire and seriou... | Class II | Invacare Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.