Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 14,651–14,700 of 15,379
- 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
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 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
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
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
Food Recall · December 6, 2023
Bobo's Oat Bars - Peach 3oz packaged in ALOX coated PET film, corrugate cartons and master case. 12 units per cartonUndeclared Allergen - Coconut
- 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
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 I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
CHEESE PIE (5 oz)Undeclared allergens; egg, milk, wheat
- 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 I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
Spanakopita, 6 oz (3 oz each piece), in plastic clam shell containerUndeclared allergens; eggs, milk, soy
- 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 I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
SPINACH PIE (2 oz)Undeclared allergens; egg, milk, wheat
- Unclassified
Vehicle Recall · December 5, 2023
2023 FORD EXPLORER, 2023 LINCOLN AVIATORLoss of the rearview camera image can reduce the driver's rear visibility, increasing the risk of a crash.
- Unclassified
Vehicle Recall · December 5, 2023
2023 FORD F-250 SD, 2023 FORD F-350 SD, 2023 FORD F-450 SDA disconnected steering column can result in a loss of steering control, increasing the risk of a crash.
- Class I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
Zucchini Mushroom PIE (5 oz)Undeclared allergens; egg, milk, wheat
- 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 I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
ASSORTED 2 OZ PIES - Cheese, Spinach, Zucchini Mushroom (12 oz)Undeclared allergens; egg, milk, wheat
- Class I
Food Recall · December 5, 2023
NBRBDR Inc. dba Nutritious Delicious Foods
SPINACH FETA PIE (5 oz)Undeclared allergens; egg, milk, wheat
- 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 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
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
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 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. 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 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. 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. 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 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 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 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.
- 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. 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.
- Unclassified
Vehicle Recall · December 4, 2023
2023 BMW X1A pinched seat belt may not function properly, increasing the risk of injury during a crash.
- 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. 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
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 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).
- Unclassified
Vehicle Recall · December 4, 2023
Honda (American Honda Motor Co.)
2023 HONDA CMX300Oil can leak onto the exhaust pipe or rear tire without the plug, increasing the risk of a fire, crash, or injury.
- 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 II
Food Recall · December 4, 2023
Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424Korean Shrimp Salad may be mislabeled as Grilled Chicken Caesar Salad: Undeclared Shellfish (shrimp), Tree nuts (Cashew), Soybeans, and Sesame.
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HConvenience 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 FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN 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" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC,Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.