Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,551–7,600 of 7,979
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software keyDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
- Class II
Medical Device Recall · December 7, 2023
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
- Class II
Medical Device Recall · December 7, 2023
Terragene Bionova PCD (PCD222-C)Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- Class II
Medical Device Recall · December 7, 2023
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCDDue to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- Class II
Medical Device Recall · December 6, 2023
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cmThe microcatheter IFU contains an intended use that has not been evaluated by the FDA.
- Class II
Medical Device Recall · December 6, 2023
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 GCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
- Class II
Medical Device Recall · December 6, 2023
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUSCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TSCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL USCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Accure Laser System, Model: PFMS00004Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
- Class II
Medical Device Recall · December 6, 2023
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mLCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cmThe microcatheter IFU contains an intended use that has not been evaluated by the FDA.
- Class II
Medical Device Recall · December 6, 2023
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 71Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TSCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) ProductCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f)Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBALCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 6, 2023
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Class II
Medical Device Recall · December 5, 2023
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination tableBackrest platform stress fracture - the table is not operational in an inclined position
- Class II
Medical Device Recall · December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination tableBackrest platform stress fracture - the table is not operational in an inclined position
- Class II
Medical Device Recall · December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination tableBackrest platform stress fracture - the table is not operational in an inclined position
- Class II
Medical Device Recall · December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}Backrest platform stress fracture - the table is not operational in an inclined position
- Class II
Medical Device Recall · December 5, 2023
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-5, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGEConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 4, 2023
Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BSAffected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-V2R, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class II
Medical Device Recall · December 4, 2023
Model No. BF-P190, EVIS EXERA III BronchovideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class I
Medical Device Recall · December 4, 2023
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDEDConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 4, 2023
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFCThe strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
- Class I
Medical Device Recall · December 4, 2023
TRACH KIT W/HYDROGEN & SALIConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 4, 2023
Model No. BF-XP190, EVIS EXERA III BronchovideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class I
Medical Device Recall · December 4, 2023
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction CatheterConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class I
Medical Device Recall · December 4, 2023
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-V2, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class II
Medical Device Recall · December 4, 2023
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class II
Medical Device Recall · December 4, 2023
Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover"Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSDConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.