Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Reason: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Root cause: Under Investigation by firm
Recalling firm: Smiths Medical ASD, Inc.Type: Stylet, Tracheal TubeDistribution: Worldwide distribution.Recall #Z-0529-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 28, 2024
AMS Artificial Urinary Sphincter Control Pump
Reason: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Root cause: Error in labeling
Recalling firm: Boston Scientific CorporationType: Device, Incontinence, Mechanical/HydraulicDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.Recall #Z-0530-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 28, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Reason: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Root cause: Error in labeling
Recalling firm: Boston Scientific CorporationType: Device, Incontinence, Mechanical/HydraulicDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.Recall #Z-0531-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 15, 2024
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and
(2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Root cause: Mixed-up of materials/components
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Recall #Z-0532-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 15, 2024
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and
(2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Root cause: Mixed-up of materials/components
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Recall #Z-0533-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 15, 2024
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Root cause: Mixed-up of materials/components
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.Recall #Z-0534-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Oct 11, 2024
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma
Model/Catalog Number: 1926740
Reason: May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: C-Reactive Protein, Antigen, Antiserum, And ControlDistribution: Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway,
Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.Recall #Z-0535-2025
Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
Achieva TX Interventional Coil 3.0T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0536-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
dS Breast 16ch 1.5T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0537-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
dS Breast 16ch 3.0T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0538-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
dS Breast 7ch 1.5T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0539-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
dS Breast 7ch 3.0T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0540-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
Mammotrak Diagnostic Coil 1.5T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0541-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
Mammotrak Interventional Coil 1.5T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0542-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
Mammotrak Diagnostic Coil 3.0T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0543-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
Mammotrak Interventional Coil 3.0T
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0544-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
SENSE Breast Coil
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0545-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
SENSE Breast Coil 3.0T 7ch
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0546-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
ST SENSE Breast Coil
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0547-2025 Open, ClassifiedPosted Nov 25, 2024·Initiated Nov 4, 2024
ST SENSE Breast Dx Coil
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Root cause: Use error
Recalling firm: Philips North America LlcType: Coil, Magnetic Resonance, SpecialtyDistribution: US Nationwide distribution.Recall #Z-0548-2025