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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,425 8k filing · 2,000 device pma
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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,425 8k filing · 2,000 device pma
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BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) — Reason: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome. — Status: Ongoing
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, — Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels. — Status: Ongoing
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications. — Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network — Status: Ongoing
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901 — Reason: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. — Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. — Status: Ongoing
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument — Reason: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction — Status: Ongoing
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. — Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. — Status: Ongoing
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. — Reason: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. — Status: Ongoing
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. — Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. — Status: Ongoing
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. — Reason: Devices are not suitable for organ transplant. — Status: Ongoing
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. — Reason: Devices are not suitable for organ transplant. — Status: Ongoing
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
DEXLOCK Achilles Repair Implant Kits, MAKT4520 — Reason: There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure. — Status: Ongoing
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 — Reason: Devices are not suitable for organ transplant. — Status: Ongoing
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration. — Reason: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. — Status: Ongoing
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile; — Reason: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. — Status: Ongoing
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 — Reason: Products may contain contamination, which may result in a darker or brown media color. — Status: Ongoing
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. — Status: Ongoing
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K — Reason: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. — Status: Ongoing