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.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceAlcon Research LLCClass IIProduct Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- 2024-08-28FDA-DeviceVentana Medical Systems, Inc.Class IIVentana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
- 2024-08-28FDA-DeviceMicrotek Medical Inc.Class IITransfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- 2024-08-28FDA-DeviceMicrotek Medical Inc.Class IIVial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- 2024-08-28FDA-DeviceMicrotek Medical Inc.Class IIBottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- 2024-08-28FDA-DeviceMicrotek Medical Inc.Class IIBag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- 2024-08-28FDA-DeviceMicrotek Medical Inc.Class IIC-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- 2024-08-28FDA-DeviceCovidienClass IMcGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
- 2024-08-28FDA-DeviceCovidienClass IMcGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
- 2024-08-28FDA-DeviceInari Medical - Oak CanyonClass IClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
- 2024-08-28FDA-DeviceBaxter Healthcare CorporationClass IISpectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
- 2024-08-28FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
- 2024-08-21FDA-DeviceArgon Medical Devices, IncClass IIL-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
- 2024-08-21FDA-DeviceDRG International, Inc.Class IIIProduct Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
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