Medical Device Recalls

7,870 medical device recalls from federal enforcement feeds.

Showing 1–50 of 7,870

• Medical Device Recall · June 5, 2026

  Philips North America Llc

  Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

  Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

  Class II

• Medical Device Recall · May 28, 2026

  Acumed LLC

  Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x

  Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

  Class II

• Medical Device Recall · May 27, 2026

  Inter-Med Llc

  Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

  Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.

  Class II

• Medical Device Recall · May 27, 2026

  Dexcom, Inc.

  Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: D

  Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.

  Class II

• Medical Device Recall · May 26, 2026

  Philips North America Llc

  Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

  Class II

• Medical Device Recall · May 26, 2026

  Philips North America Llc

  Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

  Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

  Class II

• Medical Device Recall · May 22, 2026

  Abiomed, Inc.

  Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

  Potential for thrombus formation during prolonged use of the introducer.

  Class I

• Medical Device Recall · May 22, 2026

  Abiomed, Inc.

  Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

  Potential for thrombus formation during prolonged use of the introducer.

  Class I

• Medical Device Recall · May 22, 2026

  Abiomed, Inc.

  Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

  Potential for thrombus formation during prolonged use of the introducer.

  Class I

• Medical Device Recall · May 22, 2026

  Abiomed, Inc.

  Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

  Potential for thrombus formation during prolonged use of the introducer.

  Class I

• Medical Device Recall · May 21, 2026

  BD SWITZERLAND SARL

  BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or exte

  Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

  Class II

• Medical Device Recall · May 21, 2026

  Elekta, Inc.

  MOSAIQ Oncology Information System

  Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

  Class II

• Medical Device Recall · May 20, 2026

  Zimmer, Inc.

  Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

  Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  Class II

• Medical Device Recall · May 20, 2026

  Zimmer, Inc.

  Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

  Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  Class II

• Medical Device Recall · May 20, 2026

  Zimmer, Inc.

  Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

  Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  Class II

• Medical Device Recall · May 20, 2026

  Zimmer, Inc.

  Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

  Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  Class II

• Medical Device Recall · May 20, 2026

  Zimmer, Inc.

  Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

  Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

  Class II

• Medical Device Recall · May 19, 2026

  Howmedica Osteonics Corp.

  TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

  Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

  Class II

• Medical Device Recall · May 19, 2026

  Medtronic Navigation, Inc.-Boxborough

  Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

  Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

  Class II

• Medical Device Recall · May 19, 2026

  Howmedica Osteonics Corp.

  TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

  Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

  Class II

• Medical Device Recall · May 18, 2026

  DeRoyal Industries Inc

  DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

  Sterile wound dressing, lacks sterility assurance

  Class II

• Medical Device Recall · May 18, 2026

  Abiomed, Inc.

  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

  Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

  Class I

• Medical Device Recall · May 18, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost E

  Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

  Class II

• Medical Device Recall · May 18, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD

  Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

  Class II

• Medical Device Recall · May 15, 2026

  Steris Corporation

  HarmonyAIR A-Series Surgical Lighting System

  The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

  Class II

• Medical Device Recall · May 15, 2026

  Steris Corporation

  ALYON Surgical Lighting System

  The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

  Class II

• Medical Device Recall · May 15, 2026

  Steris Corporation

  HarmonyAIR A-Series Surgical Lighting System

  There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Lapa

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxi

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  Abiomed, Inc.

  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-

  Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

  Class I

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Lapar

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxi

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 14, 2026

  ConMed Corporation

  ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dio

  Potential for overpressure alerts.

  Class II

• Medical Device Recall · May 13, 2026

  Thoratec LLC

  Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Ba

  Due to 11 volt Backup Battery failures.

  Class II

• Medical Device Recall · May 13, 2026

  Medtronic Neuromodulation

  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor

  A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

  Class II

• Medical Device Recall · May 13, 2026

  Medtronic Neuromodulation

  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

  A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

  Class II

• Medical Device Recall · May 13, 2026

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central

  Due to 11 volt Backup Battery failures.

  Class II

• Medical Device Recall · May 13, 2026

  Thoratec LLC

  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assi

  Due to 11 volt Backup Battery failures.

  Class II

• Medical Device Recall · May 12, 2026

  Abbott Medical

  Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

  Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

  Class II

• Medical Device Recall · May 12, 2026

  Medtronic Perfusion Systems

  Octopus Evolution AS Tissue Stabilizer, Model TS2500

  During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

  Class II

• Medical Device Recall · May 12, 2026

  Boston Scientific Corporation

  Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastroint

  Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

  Class II

• Medical Device Recall · May 12, 2026

  Medtronic Perfusion Systems

  Octopus 4 Tissue Stabilizer, Model 29400

  During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

  Class II

• Medical Device Recall · May 12, 2026

  Fresenius Medical Care Holdings, Inc.

  Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

  Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

  Class II

• Medical Device Recall · May 12, 2026

  Medtronic Perfusion Systems

  Octopus Evolution Tissue Stabilizer, Model TS2000

  During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

  Class II