Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 5 months ago
Hologic, Inc Selenia Dimensions Mammography Systems. Model Numbers recall: Complaints have been received of systems developing loose, missing
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
-
Class II · 5 months ago
Stryker Sustainability Solutions BARD Dynamic Deca Steerable, Product Number 201101 recall: Incomplete seals on sterile product
Incomplete seals on sterile product
-
Class II · 5 months ago
Djo, LLC Brand Name: Donjoy Product Name: Iceman W/,Univ,Loop,NS,EH Model/ recall: Due to broken connector which may result in a temporary interruption
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
-
Class II · 5 months ago
Microvention Inc. LVIS Intraluminal Support Device, REF/Outside Diameter xTotal Length recall: Stent-assisted coiling device may due to commingling during manufacturing
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If…
-
Class II · 5 months ago
Stryker Sustainability Solutions Bard Dynamic Tip Steerable, Product Number 6Dyntp001 recall: Incomplete seals on sterile product
Incomplete seals on sterile product
-
Class II · 5 months ago
GE Medical Systems, LLC Revolution CT ES, X-ray Computed Tomography recall: GE HealthCare has become aware of a potential security vulnerability
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart…
-
Class I · 5 months ago
Medline medical convenience kits, containing Namic Manifold recall: Medline has identified the presence of particulate within the fluid path
Medline has identified the presence of particulate within the fluid path of the Manifolds.
-
Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
-
Class I · 6 months ago
Cook Incorporated Beacon Tip Centimeter Sizing Catheter RPN/GPN recall: Marker bands may be at an increased risk of cracking/breakage. Potential
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms…
-
Class II · 6 months ago
Biofire Spotfire recall: Respiratory/sore throat panel test may result in false negative results
Respiratory/sore throat panel test may result in false negative results and control failures.
-
Class II · 6 months ago
Medline Convenience Kits: 1) Chest Tube Insertion Tray recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
-
Class II · 6 months ago
Mint Lesion recall: If the connection between a mint Lesion workstation and the mint Lesion
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information…
-
Class I · 6 months ago
Cook Incorporated Aurous Centimeter Sizing Catheter RPN recall: Marker bands may be at an increased risk of cracking/breakage. Potential
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms…
-
Class I · 6 months ago
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 recall: Reloads for curved-tipped stapler may potentially produce an incomplete
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
-
Class II · 6 months ago
Medline Convenience Kits: 1) KIT Triple Lumen Insertion recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
-
Class I · 6 months ago
Cook Incorporated Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN recall: Marker bands may be at an increased risk of cracking/breakage. Potential
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms…
-
Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
-
Class II · 6 months ago
Erbeflo 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 recall: Devices providing sterile water/CO2/air to endoscopes were manufactured
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more…
-
Class II · 6 months ago
Erbeflo CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201 recall: Devices providing sterile water/CO2/air to endoscopes were manufactured
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more…
-
Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Spinal CDS recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
-
Class I · 6 months ago
AVID Medical, Inc. Halyard Perc Tray kit. Model Numbers: Slpc34-01, Slpc34-02 recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
-
Class II · 6 months ago
See RES for full list. Medline Convenience Kits: 1) CHP Cochlear recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
-
Class II · 6 months ago
Medline Convenience Kits: 1) KIT General Closure recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
-
Class II · 6 months ago
See complete list in RES, exceeds character limit. Medline Surgical recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…