FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 3, 2026. New recalls appear here on the FDA's own publishing schedule.

59,102 recall(s)

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 30, 2026

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.

Reason: Potential for breach in sterile barrier of device packaging.

Root cause: Process control

Recalling firm: Boston Scientific CorporationType: Forceps, Biopsy, Non-ElectricDistribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.Recall #Z-2840-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2841-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2842-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2843-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2844-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2845-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2846-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2847-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2848-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2849-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2850-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2851-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2852-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Reason: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Root cause: Under Investigation by firm

Recalling firm: Pride Mobility Products Corp.Type: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution including in the states of AZ, NJ, PA, OK, CO, IN, AR, KS, CT, MD, WI, TX, FL, WA, NY, MO, LA, UT, OR, VA, RI, CA, TN, MN, KY, NV, GA, WV, IL, OH, SC, WY, AL, MI, ME, NC, SD, DE, MA, NE, ND, IA, NH, NM, MT, ID, MS, DC, AK and the countries of Canada and Australia.Recall #Z-2853-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 16, 2026

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user interface of WASPLab device.

Reason: Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.

Root cause: Under Investigation by firm

Recalling firm: Copan WASPType: Calculator/Data Processing Module, For Clinical UseDistribution: US Nationwide distribution in the state of Arizona.Recall #Z-2854-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Mar 23, 2026

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Reason: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Root cause: Component design/selection

Recalling firm: THERANICA BIOELECTRONICS LTDType: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute MigraineDistribution: The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-userRecall #Z-2855-2026

Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 19, 2026

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

Reason: A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.

Root cause: Software Design Change

Recalling firm: MUNEVO GMBHType: Components, WheelchairDistribution: Worldwide - US Nationwide distribution in the states of California, Florida, North Carolina, Texas, Utah, and Washington. The countries of United Kingdom, Spain, Italy, Germany, and Switzerland.Recall #Z-2856-2026

Open, ClassifiedPosted Jul 30, 2026·Initiated May 11, 2026

Power Over Fiber Base Module

Reason: Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Terex UtilitiesType: Fiber Optic Communication And Data TransferDistribution: U.S. Nationwide Distribution and International DistributionRecall #Z-2745-2026

Open, ClassifiedPosted Jul 30, 2026·Initiated May 13, 2026

Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds

Reason: Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.

Root cause: Material/Component Contamination

Recalling firm: Medical Action Industries, Inc. 306Type: Cardiovascular Procedure KitDistribution: US: AZ, CORecall #Z-2792-2026

Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system.

Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

Root cause: Software Design Change

Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2821-2026