Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 1,601–1,650 of 7,959

• Medical Device Recall · November 12, 2025

  Howmedica Osteonics Corp.

  The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit fo

  When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

  Class II

• Medical Device Recall · November 12, 2025

  Remel, Inc

  1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

  Products may contain contamination, which may result in a darker or brown media color.

  Class II

• Medical Device Recall · November 12, 2025

  Cardinal Health 200, LLC

  ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Med

  Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Medline Industries, LP

  DEXLOCK Achilles Repair Implant Kits, MAKT4520

  There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

  Class II

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 10, 2025

  Beckman Coulter, Inc.

  COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all

  Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

  Class II

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a me

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I

• Medical Device Recall · November 10, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

  The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

  Class II

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mecha

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, wi

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, wi

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 7, 2025

  Intuitive Surgical, Inc.

  Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinc

  Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

  Class II

• Medical Device Recall · November 7, 2025

  Beckman Coulter, Inc.

  Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

  It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

  Class II

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 7, 2025

  Rocket Medical Plc

  Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a bar

  IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

  Class II

• Medical Device Recall · November 6, 2025

  CareFusion 303, Inc.

  BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent a

  Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network

  Class II

• Medical Device Recall · November 6, 2025

  C.R. Bard Inc

  BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

  Class II

• Medical Device Recall · November 6, 2025

  C.R. Bard Inc

  BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

  Class II

• Medical Device Recall · November 6, 2025

  PATH

  MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

  Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.

  Class II

• Medical Device Recall · November 6, 2025

  C.R. Bard Inc

  Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

  Class II

• Medical Device Recall · November 6, 2025

  C.R. Bard Inc

  BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

  Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

  Class II

• Medical Device Recall · November 6, 2025

  Bard Peripheral Vascular Inc

  Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

  Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

  Class II

• Medical Device Recall · November 5, 2025

  Diasol, Inc

  Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

  Safety and efficacy of dialysis acid concentrate cannot be assured

  Class II

• Medical Device Recall · November 5, 2025

  Diasol, Inc

  Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

  Safety and efficacy of dialysis acid concentrate cannot be assured

  Class II