Medical Device Recalls

8,553 medical device recalls from federal enforcement feeds.

Showing 751–800 of 8,553

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 4, 2026

  Medline Industries, LP

  MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,T

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

  Class II

• Medical Device Recall · May 1, 2026

  GE Medical Systems, LLC

  Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

  GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · May 1, 2026

  GE Medical Systems, LLC

  Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

  GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

  Class II

• Medical Device Recall · May 1, 2026

  GE Medical Systems, LLC

  Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

  GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · May 1, 2026

  Philips North America Llc

  DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

  System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

  Class II

• Medical Device Recall · May 1, 2026

  INSPIREMD Inc

  Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

  Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

  TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

  An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

  Class II

• Medical Device Recall · April 30, 2026

  AVID Medical, Inc.

  Halyard, Pain Pack. Kit Code: AMPK48-01.

  Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  Accriva Diagnostics, Inc.

  directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

  Assayed Whole blood control contains labeling with incorrect performance range.

  Class II

• Medical Device Recall · April 30, 2026

  Advanced Bionics, LLC

  Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ea

  Due to incorrect shelf-life expiration date.

  Class II

• Medical Device Recall · April 30, 2026

  CareFusion 303, Inc.

  BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

  Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  AVID Medical, Inc.

  Halyard, Towel Six Pack. Kit Code: AMTS70-01.

  Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  AVID Medical, Inc.

  Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

  Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

  Class I

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  CareFusion 303, Inc.

  BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

  Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

  Class II

• Medical Device Recall · April 30, 2026

  CareFusion 303, Inc.

  BD Pyxis MedStation 4000 REF: 303 Medication cabinet

  Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

  Class II

• Medical Device Recall · April 30, 2026

  CareFusion 303, Inc.

  BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

  Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  CareFusion 303, Inc.

  BD Pyxis MedStation ES REF: 323 Medication cabinet

  Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  Avanos Medical, Inc.

  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit

  Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  SURGIFY MEDICAL OY

  Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

  Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

  Class II

• Medical Device Recall · April 30, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper

  It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

  Class II