Medical Device Recalls

8,553 medical device recalls from federal enforcement feeds.

Showing 1–50 of 8,553

• Medical Device Recall · August 24, 2026

  Boston Scientific Corporation

  Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 B

  Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

  Class I

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Midmark Corporation

  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients

  A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

  Class II

• Medical Device Recall · August 21, 2026

  Midmark Corporation

  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients

  A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  MR 5300 Model Number (REF): 1. 782110, 2. 782152;

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Inte

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Midmark Corporation

  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients

  A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 21, 2026

  Midmark Corporation

  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients

  A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

  Class II

• Medical Device Recall · August 21, 2026

  Philips North America Llc

  Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

  A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  Class II

• Medical Device Recall · August 20, 2026

  Wilson-Cook Medical Inc.

  Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemost

  Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

  Class II

• Medical Device Recall · August 20, 2026

  ICU Medical, Inc.

  CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24

  Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

  Class II

• Medical Device Recall · August 20, 2026

  DeRoyal Industries Inc

  REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

  Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

  Class II

• Medical Device Recall · August 19, 2026

  Olympus Corporation of the Americas

  Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

  Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Olympus Corporation of the Americas

  Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

  Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

  Class II

• Medical Device Recall · August 19, 2026

  BD SWITZERLAND SARL

  BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Ala

  Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

  Class I

• Medical Device Recall · August 19, 2026

  SEASPINE ORTHOPEDICS CORPORATION

  SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

  The proximal thread depth of the spinal device is out of design specification.

  Class II

• Medical Device Recall · August 19, 2026

  Olympus Corporation of the Americas

  Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

  Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Olympus Corporation of the Americas

  Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

  Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

  Class II

• Medical Device Recall · August 19, 2026

  NOXBOX LTD

  NOxBOXi Nitric Oxide Delivery System.

  Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Stryker Sustainability Solutions

  REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM

  Reusable access port system may crack or seperate during use.

  Class II

• Medical Device Recall · August 19, 2026

  Olympus Corporation of the Americas

  Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

  Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

  Class II

• Medical Device Recall · August 18, 2026

  Baxter Healthcare Corporation

  PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

  Class II

• Medical Device Recall · August 18, 2026

  Baxter Healthcare Corporation

  PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a pa

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

  Class II

• Medical Device Recall · August 18, 2026

  Baxter Healthcare Corporation

  PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

  Class II

• Medical Device Recall · August 18, 2026

  Olympus Corporation of the Americas

  POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

  Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

  Class II

• Medical Device Recall · August 12, 2026

  CooperVision, Inc.

  Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

  A small number of lenses within the affected lot are of the incorrect power.

  Class II

• Medical Device Recall · August 12, 2026

  Straumann USA LLC

  GM Helix Implant, REF: 109.984;

  There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

  Class II

• Medical Device Recall · August 12, 2026

  Abiomed, Inc.

  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; P

  The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

  Class I

• Medical Device Recall · August 12, 2026

  Abiomed, Inc.

  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller,

  The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

  Class I

• Medical Device Recall · August 12, 2026

  Abiomed, Inc.

  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged

  The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

  Class I

• Medical Device Recall · August 12, 2026

  INTERVASCULAR, SAS

  Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;

  Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

  Class II

• Medical Device Recall · August 11, 2026

  CooperSurgical, Inc.

  INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.

  Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

  Class I

• Medical Device Recall · August 11, 2026

  Medline Industries, LP

  Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

  The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

  Class I

• Medical Device Recall · August 11, 2026

  Medline Industries, LP

  Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F

  The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

  Class I

• Medical Device Recall · August 11, 2026

  Medline Industries, LP

  Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726

  The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

  Class I

• Medical Device Recall · August 11, 2026

  Becton, Dickinson and Company

  ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin o

  Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

  Class II

• Medical Device Recall · August 11, 2026

  Medline Industries, LP

  Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080

  The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

  Class I