86 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
FDA Recall
Open, Classified
·Omega Medical Imaging, Inc.·Product code IWE·September 8, 2023
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
FDA Recall
Open, Classified
·Omega Medical Imaging, Inc.·Product code IWE·February 28, 2023
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
FDA Recall
Open, Classified
·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IWE·August 27, 2025
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
FDA Recall
Open, Classified
·Product code KWS·August 4, 2023
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
FDA Recall
Open, Classified
·Product code LZO·August 4, 2023
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
FDA Recall
Open, Classified
·Product code JWH·August 4, 2023
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
FDA Recall
Open, Classified
·Product code KWA·August 4, 2023
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
FDA Recall
Open, Classified
·Product code PHX·August 4, 2023
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
FDA Recall
Open, Classified
·Arrow International Inc·Product code N/A·May 19, 2021
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code KOD·September 20, 2022
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
FDA Recall
Open, Classified
·Arrow International Inc·Product code N/A·May 19, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
FDA Recall
Open, Classified
·Arrow International Inc·Product code N/A·May 19, 2021
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·December 8, 2022
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
FDA Recall
Open, Classified
·Arrow International Inc·Product code N/A·May 19, 2021
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·December 8, 2022
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
FDA Recall
Open, Classified
·Arrow International Inc·Product code KNW·March 8, 2021
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
FDA Recall
Open, Classified
·Belmont Instrument LLC·Product code FRN·January 2, 2025
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·December 8, 2022
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·April 28, 2025
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code QJR·April 28, 2025