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Showing 7561–7580 of 11714 results

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Alprazolam C-IV 0.5mg (Direct Rx) – Cross Contamination Risk (2023)

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIModerate

FDAMar 22, 2023Nationwide• Direct Rx

Alprazolam C-IV 2mg (Direct Rx) – Cross Contamination Risk (2023)

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIModerate

FDAMar 22, 2023Nationwide• Direct Rx

ASM Replacement Battery (ICU Medical) – early capacity loss (2023)

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Low

FDAMar 22, 2023Nationwide• ICU Medical Inc

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

FDAMar 21, 2023NV, NY• Linkbio Corp.

Aesculap Caiman Articulating Device (Aesculap) – spring detachment risk (2023)

Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

FDAMar 21, 2023Nationwide• Aesculap Implant Systems LLC

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

FDAMar 21, 2023NV, NY• Linkbio Corp.

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

FDAMar 21, 2023NV, NY• Linkbio Corp.

ARTIS One Angiography System (Siemens) – monitor display issue (2023)

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

FDAMar 21, 2023Nationwide• Siemens Medical Solutions USA, Inc

Philips Azurion System (Philips) – X-ray functionality loss (2023)

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

FDAMar 21, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

LINK SLED Knee System (Linkbio) – surgical technique warning (2023)

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

FDAMar 21, 2023NV, NY• Linkbio Corp.

COBRA-OS Sheath Introducer (Merit Medical) – incorrect needle size (2023)

Custom sheath Introducer contains incorrect needle size

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

ExactaMed Oral Dispenser (Baxter) – particulate matter risk (2023)

ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.

FDAMar 20, 2023Nationwide• Baxter Healthcare Corporation

DermLite DL4W (DermLite) – incorrect serial number (2023)

Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

FDAMar 20, 2023Nationwide• DermLite LLC

Philips Incisive CT System (Philips) – foot switch entrapment (2023)

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

FDAMar 20, 2023Nationwide• Philips North America

CryoTreQ Surgical Device (Beaver Visitec) – disassembly risk (2023)

Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.

FDAMar 17, 2023Nationwide• Beaver Visitec International, Inc.

Spectral CT 7500 System (Philips) – foot switch entrapment (2023)

Laceration Risk

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

FDAMar 17, 2023Nationwide• Philips North America Llc

Steris Light Handle Cover (Steris) – detachment risk (2023)

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

FDAMar 17, 2023Nationwide• Steris Corporation

Medtronic SenSight Tunneler Kit (Medtronic) – carrier machining issue (2023)

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

FDAMar 17, 2023Nationwide• Medtronic Neuromodulation

Aripiprazole Tablets (Ascend Laboratories) – Spectroscopic Test Failure (2023)

Out of specification (OOS) for Spectroscopic Identification test by IR.

Class IIModerate

FDAMar 17, 2023Nationwide• Ascend Laboratories, LLC

V. Mueller Graves Speculum (Carefusion) – product mismatch (2023)

A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.

FDAMar 16, 2023AL, AZ, AR +33 more• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

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