Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 301–350 of 8,553
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · June 30, 2026
Merge OrthoPACS, medical imaging diagnostic workstationThumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
- Class II
Medical Device Recall · June 30, 2026
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.The module did not undergo electrical safety tests and functional tests during production.
- Class II
Medical Device Recall · June 30, 2026
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
- Class II
Medical Device Recall · June 30, 2026
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware producDue to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 30, 2026
Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
- Class II
Medical Device Recall · June 30, 2026
Merge PACS, medical imaging diagnostic workstationThumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
- Class II
Medical Device Recall · June 30, 2026
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240Potential for breach in sterile barrier of device packaging.
- Class II
Medical Device Recall · June 30, 2026
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 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.Potential for breach in sterile barrier of device packaging.
- Class II
Medical Device Recall · June 30, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SCPotential for breach in sterile barrier of device packaging.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class I
Medical Device Recall · June 30, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration SetsBaxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 29, 2026
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HThe Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Class II
Medical Device Recall · June 29, 2026
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Class II
Medical Device Recall · June 29, 2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Class II
Medical Device Recall · June 29, 2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Class II
Medical Device Recall · June 29, 2026
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
- Class II
Medical Device Recall · June 29, 2026
GE Medical Systems Information Technologies Inc
GE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographSoftware issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
- Class II
Medical Device Recall · June 29, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.Firmware issue potentially leading to loss of geometry movements.
- Class II
Medical Device Recall · June 26, 2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
- Class II
Medical Device Recall · June 26, 2026
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B101Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Class II
Medical Device Recall · June 26, 2026
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus InsAnalyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Class II
Medical Device Recall · June 26, 2026
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Potential of failing to trigger clinical scan during Bolus Tracking.
- Class III
Medical Device Recall · June 26, 2026
Siemens Healthcare Diagnostics, Inc.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
- Class III
Medical Device Recall · June 26, 2026
Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219ULout-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
- Class II
Medical Device Recall · June 26, 2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension TubBlack depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
- Class II
Medical Device Recall · June 25, 2026
Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray andDue to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Class II
Medical Device Recall · June 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 ComponenIf 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.
- Class II
Medical Device Recall · June 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.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.
- Class II
Medical Device Recall · June 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: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.
- Class I
Medical Device Recall · June 25, 2026
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventDue to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
- Class II
Medical Device Recall · June 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 CompIf 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.
- Class II
Medical Device Recall · June 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 ComponIf 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.
- Class II
Medical Device Recall · June 25, 2026
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Class II
Medical Device Recall · June 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: ContrIf 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.
- Class II
Medical Device Recall · June 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)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.
- Class II
Medical Device Recall · June 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), 89If 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.
- Class II
Medical Device Recall · June 25, 2026
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 108017410249Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Class II
Medical Device Recall · June 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 CoIf 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.
- Class II
Medical Device Recall · June 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: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.
- Class II
Medical Device Recall · June 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: ContrIf 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.
- Class II
Medical Device Recall · June 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), 890.38If 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.
- Class II
Medical Device Recall · June 25, 2026
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.