August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Biopsy Drape Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Cataract Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American C
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Special Procedure Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Gyn Laparoscopy convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Hand Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
August 14, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pac
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 14, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 14, 2024Medical DevicesFDA
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI
Hazard: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
August 14, 2024Medical DevicesFDA
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Hazard: Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
August 14, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.
August 14, 2024Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicate
Hazard: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
August 14, 2024Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate
Hazard: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
August 14, 2024Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicat
Hazard: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
August 14, 2024Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate
Hazard: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
August 14, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wi
Hazard: Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Hazard: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Hazard: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Hazard: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
August 14, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.