Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 6,601–6,650 of 8,689

Medical Device Recall · June 3, 2024
Qiagen Sciences LLC
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Class II
Medical Device Recall · June 3, 2024
Fresenius Medical Care Holdings, Inc.
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class II
Medical Device Recall · June 3, 2024
Stryker Corporation
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then ins
Expired Products distributed to customers
Class II
Medical Device Recall · June 3, 2024
Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class II
Medical Device Recall · June 3, 2024
Stryker Corporation
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the abil
Expired Products distributed to customers
Class II
Medical Device Recall · June 3, 2024
Baxter Healthcare Corporation
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardia
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
Class II
Medical Device Recall · June 2, 2024
Treace Medical Concepts, Inc.
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Class II
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Zoll Medical Corporation
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, tha
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Class II
Medical Device Recall · May 31, 2024
Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Class II
Medical Device Recall · May 31, 2024
Smiths Medical ASD Inc.
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Class I
Medical Device Recall · May 31, 2024
Radiometer Medical ApS
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , c
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Smiths Medical ASD Inc.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Class I
Medical Device Recall · May 31, 2024
Smiths Medical ASD Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Class I
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II
Medical Device Recall · May 31, 2024
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Class I
Medical Device Recall · May 31, 2024
Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Class II
Medical Device Recall · May 31, 2024
Smiths Medical ASD Inc.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Class I
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Avanos Medical, Inc.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Con
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 47552
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Materi
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class II
Medical Device Recall · May 31, 2024
Stryker Sustainability Solutions
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Class II
Medical Device Recall · May 30, 2024
Baxter Healthcare Corporation
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class I
Medical Device Recall · May 30, 2024
Dental EZ Group Star Dental Division
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Class II
Medical Device Recall · May 30, 2024
Dental EZ Group Star Dental Division
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival sca
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Class II
Medical Device Recall · May 30, 2024
Baxter Healthcare Corporation
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class I
Medical Device Recall · May 29, 2024
Cardinal Health 200, LLC
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPH
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDA
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Baxter Healthcare Corporation
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system in
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm T
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGH
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE ,
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, P
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Cardinal Health 200, LLC
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurolo
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Co
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I
Medical Device Recall · May 29, 2024
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
Class II
Medical Device Recall · May 29, 2024
Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Class I