Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-09-11FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IISevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
- 2024-09-11FDA-DeviceCareFusion 303, Inc.Class IIBKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- 2024-09-11FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- 2024-09-11FDA-DeviceW L Gore & Associates, Inc.Class IIHeparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
Due to packaging defects, sterility assurance and heparin activity may be compromised.
- 2024-09-11FDA-DeviceW L Gore & Associates, Inc.Class IIHeparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB
Due to packaging defects, sterility assurance and heparin activity may be compromised.
- 2024-09-11FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-09-11FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo Universal Ventilator, Model No. DS2000X11B
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-09-11FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Tril
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-09-11FDA-DeviceFresenius Kabi USA, LLCClass ILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
- 2024-09-11FDA-DeviceBreas Medical, Inc.Class IVivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
- 2024-09-11FDA-DeviceBeckman Coulter, Inc.Class IIDxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
- 2024-09-04FDA-DeviceORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICALClass IIFRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
- 2024-09-04FDA-DeviceCypress Medical Products LLCClass IIMcKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Affected syringes lack FDA clearance.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 2024-09-04FDA-DeviceBeaver Visitec International, Inc.Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
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