July 2022 recalls

561 recalls were announced in July 2022.

What the numbers show

Critical: 6
Severe: 99
High: 413
Moderate: 40
Low: 3

Of the 561 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.

Which agencies issued them

301–400 of 561

HighFDA (Drugs)·D-1233-2022·2022-07-20
Compounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance
Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was distributed nationwide in the USA and Puerto Rico.
Product
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V511000·2022-07-20
2021-2023 Tiffin Motorhomes Recalled for Propane Leak Risk
Tiffin is recalling certain 2021-2023 Allegro and related motorhomes due to a defective LPG tank connection that may cause propane leaks and fire risk. Free inspection and repair are available through Tiffin dealers.
Product
TIFFIN — TIFFIN ALLEGRO, ALLEGRO BAY, ALLEGRO BREEZE, ALLEGRO RED
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1212-2022·2022-07-20
Melanotan I Injectable Vials Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. The affected vials were distributed nationwide and in Puerto Rico.
Product
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1231-2022·2022-07-20
Testosterone Cypionate Injections Recalled for Sterility Assurance Failure
Tailor Made Compounding recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
Product
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2022·2022-07-20
Ivenix Infusion System Devices Recalled for Alarm Sequencing Defect
The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.
Product
Ivenix Infusion System (IIS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1419-2022·2022-07-20
1st Phorm Protein Bars Recalled for Plastic and Paper Contamination
Bakery Barn is recalling 1st Phorm Level-1 Bar Chocolate Crunch protein bars due to possible contamination with plastic and paper foreign material. Consumers should not consume the affected product.
Product
1st Phorm High Quality Protein Level-1 Bar Chocolate Crunch Protein Bars. 15 Bars Per Box. Net Wt. 12-2.22oz (63g) Bars 33.3oz (945g) Per Box. UPC: 5002619600
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1379-2022·2022-07-20
Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
Product
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1382-2022·2022-07-20
Vivo 45LS Ventilator processor failure alarm not generated on shutdown
Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.
Product
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2022·2022-07-20
MiniMed 740G Insulin Pump Recalled Due to Battery Cap Deterioration and Power Loss Risk
Medtronic recalls certain MiniMed 740G Insulin Pumps due to battery cap deterioration that may cause loss of power and functionality. No illnesses have been reported.
Product
MiniMed 740G Insulin Pump (O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1215-2022·2022-07-20
Injectable Methylcobalamin recalled due to lack of sterility assurance
Tailor Made Compounding is recalling 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
Product
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1207-2022·2022-07-20
Gonadorelin Drug Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1201-2022·2022-07-20
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Product
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2022·2022-07-20
Aesculap Micro Needleholder Recalled for Incorrect Size Labeling
Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.
Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Category
Medical Device
Distribution
2 states
HighFDA (Drugs)·D-1237-2022·2022-07-20
FDA Recalls Compounded Testosterone Injection for Sterility Assurance
Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.
Product
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2022·2022-07-20
HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm
Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Category
Medical Device
Distribution
6 states
HighNHTSA·22V517000·2022-07-20
2023 Thomas Built Buses Saf-T-Liner EFX Recalled for Emergency Exit Defect
Daimler Trucks North America is recalling 2023 Thomas Built Buses Saf-T-Liner EFX school buses because they may lack sufficient emergency exits, increasing injury risk during emergencies.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V512000·2022-07-20
Alliance RV Paradigm and Valor Travel Trailers Awning Weld Separation
Alliance RV is recalling 2022-2023 Paradigm and Valor travel trailers due to electric retractable awning weld separation that may allow the awning to drop unexpectedly, increasing injury risk.
Product
ALLIANCE RV — ALLIANCE RV PARADIGM, VALOR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1230-2022·2022-07-20
Testosterone Cypionate Injectable Vials Recalled Due to Sterility Assurance Concerns
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
Product
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1371-2022·2022-07-20
Hemodialysis Dialysate Recalled for Unqualified Bottle Caps
Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.
Product
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1228-2022·2022-07-20
Sermorelin/Glycine Injectable Recalled for Lack of Sterility Assurance
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
Product
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2022·2022-07-20
Modular Orthopedic Implant Screws May Not Loosen During Surgery
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
Product
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1359-2022·2022-07-20
MiniMed 780G Insulin Pump battery cap deterioration may cause power loss
Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.
Product
MiniMed 780G Insulin Pump (O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1367-2022·2022-07-20
Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions
Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.
Product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1220-2022·2022-07-20
Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
Product
Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1219-2022·2022-07-20
NAD+ Injectable Vials Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Product
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2022·2022-07-20
MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration
Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.
Product
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1358-2022·2022-07-20
MiniMed 770G Insulin Pump Battery Cap May Deteriorate, Causing Power Loss
Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.
Product
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1364-2022·2022-07-20
AquaBplus Water Purification System installation guideline error reduces disinfection
AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.
Product
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2022·2022-07-20
MiniMed 620G insulin pump battery cap deterioration may cause power loss
Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.
Product
MiniMed 620G Insulin Pump (O.U.S. version)
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1368-2022·2022-07-20
Dental bonding primer may lack resin component affecting restoration
Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.
Product
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1210-2022·2022-07-20
Compounded injectable product recalled for lack of sterility assurance
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
Product
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1206-2022·2022-07-20
Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.
Product
Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2022·2022-07-20
Isopure IsoMix PRO Mixing System Electrical Short Recall
Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.
Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Category
Medical Device
Distribution
23 states
HighFDA (Drugs)·D-1218-2022·2022-07-20
Methylene Blue Hypotonic Solution Vials Recalled for Sterility Assurance Failure
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
Product
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1412-2022·2022-07-20
Slap Ya Mama Cajun Fish Fry Recalled for Undeclared Wheat Allergen
Walker & Sons Inc is recalling Slap Ya Mama Cajun Fish Fry due to undeclared wheat allergen. Consumers with wheat allergies should not consume the product.
Product
Slap Ya Mama Louisiana Food Products Slap Ya Mama Cajun Fish Fry packaged in a 5.5lb plastic container with plastic screw top - 4 units per case UPC 8 17885 00027 4
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1326-2022·2022-07-20
Radiography System Firmware Error May Cause Incorrect Radiation Dose
Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.
Product
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1222-2022·2022-07-20
Procaine HCL Injectable Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Product
Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2022·2022-07-20
Philips ProxiDiagnost N90 radiography system: firmware issue causes incorrect radiation dose
Philips is recalling 140 ProxiDiagnost N90 radiography systems due to a firmware issue in the Wallstand VS2 component. After system restart or first exposure with Wallstand VS2, the system may deliver incorrect radiation doses and misposition anatomic markers.
Product
ProxiDiagnost N90. radiography and fluoroscopy system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2022·2022-07-20
MiniMed 670G Insulin Pump Battery Cap Defect Causing Power Loss
MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.
Product
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1243-2022·2022-07-20
Glutathione Injectable Vials Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
Product
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1203-2022·2022-07-20
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.
Product
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1223-2022·2022-07-20
PT-141 10mg/mL Injectable Vials Recalled for Sterility Assurance Concerns
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
Product
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1224-2022·2022-07-20
Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.
Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1236-2022·2022-07-20
Compounded Testosterone Injection Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
Product
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1235-2022·2022-07-20
Testosterone Injections Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.
Product
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V514000·2022-07-20
Volkswagen Atlas Cross Sport Rearview Camera Software Defect Recall
Volkswagen is recalling certain 2021-2022 Atlas Cross Sport vehicles due to an infotainment system defect that may prevent the rearview camera image from displaying. This loss of rear visibility increases crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN TAOS, ATLAS, TIGUAN, JETTA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V515000·2022-07-20
Audi Recalls 2022 A3 and S3 Sedans for Seat Belt Tensioner Defect
Volkswagen Group of America is recalling 2,584 2022 Audi A3 and S3 sedans because the seat belt tensioners may not restrain occupants properly during a crash.
Product
AUDI — AUDI A3, S3
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1213-2022·2022-07-20
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
Product
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1227-2022·2022-07-20
Compounded Sermorelin/Glycine Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
Product
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1417-2022·2022-07-20
Market Day Krabbycakes Recalled for Undeclared Shrimp
Market Day Krabbycakes (840 bags, Item 3320) are being recalled because they contain undeclared shrimp and carmine colorant. The product was distributed across multiple states; consumers with shellfish allergies should not consume it.
Product
Market Day Krabbycakes, Item 3320, Net Wt. 40 oz. (2.5 lbs.) 1.13kg. Item Number 803320R. UPC 51497 14360. Light panko Breadcrumbs blended with Snow Crab meat, Fresh Cream & Real Butter with Seasonings. Keep Frozen - Fully Cooked. Distributed & Sold exclusively by: Market…
Category
Food
Distribution
15 states
HighFDA (Drugs)·D-1205-2022·2022-07-20
Glutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues
Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
Product
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1211-2022·2022-07-20
Levocarnitine Injection Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
Product
Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1190-2022·2022-07-20
Testosterone Cypionate Injection Recalled for Water Leakage in Manufacturing
Sun Pharmaceutical recalls 50,860 vials of Testosterone Cypionate Injection due to water leakage during manufacturing that could affect product sterility. The firm-initiated recall was reported in July 2022 and affects nationwide distribution.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2022·2022-07-20
CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints
Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.
Product
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Category
Medical Device
Distribution
52 states
HighFDA (Drugs)·D-1202-2022·2022-07-20
Folic Acid Injectable Vials Recalled Due to Sterility Concerns
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
Product
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1204-2022·2022-07-20
Compounded Injectable Amino Acid Drug Recalled for Sterility Assurance Issues
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
Product
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1192-2022·2022-07-20
Alpha Lipoic Acid injectable vials recalled for sterility assurance failure
TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was distributed nationwide.
Product
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1194-2022·2022-07-20
Compounded Testosterone-Anastrozole Injectable Vials Recalled for Sterility Concerns
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
Product
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1234-2022·2022-07-20
Testosterone injectable drug recall due to lack of sterility assurance
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
Product
Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1200-2022·2022-07-20
Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Product
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1369-2022·2022-07-20
Invacare Platinum 5NXG Oxygen Concentrator Recall Due to Missing Rx Only Label Statement
Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1361-2022·2022-07-20
Medical device manufacturer recalls mislabeled interference screws nationwide
SCIENCE & BIO MATERIALS has recalled ComposiTCP 30 Interference screws due to mislabeling. The recall affects 72 units distributed nationwide in the US.
Product
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1416-2022·2022-07-20
Goodman Gluten Free Apple Pie Recalled Due to Undeclared Cinnamon
Goodman Food Products is recalling GOODMAN GLUTEN FREE Vegan Apple Pie due to undeclared cinnamon in products with lot numbers 22088, 22089, and 22118. The recall affects North Carolina, South Carolina, and New Jersey.
Product
GOODMAN GLUTEN FREE; Vegan Apple Pie, Fully Baked 16.4 oz, paperboard box; INGREDIENTS: Apples, Potato Starch, Palm Oil, Sugar, Brown Rice Flour, White Rice Flour, Dextrose, Xanthan Gum, Salt. Processed in a facility that also processes: Egg, Tree Nuts; Manufactured for GOODMAN…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1351-2022·2022-07-20
Philips LAS-100 Laser System may not operate due to detected hardware failure
Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.
Product
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-1375-2022·2022-07-20
Cathcart Hip Ball prosthesis recalled for missing surgical technique specification
DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.
Product
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1348-2022·2022-07-20
CoolCurve ZELTIQ vacuum applicators withdrawn due to increased Paradoxical Hyperplasia complaints
Zeltiq Aesthetics is removing 703 CoolCurve ZELTIQ vacuum applicators due to increased complaints of Paradoxical Hyperplasia reported between 2019 and 2021.
Product
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Category
Medical Device
Distribution
52 states
ModerateFDA (Devices)·Z-1384-2022·2022-07-20
Anti-FITC-AP CISH Kit Label Bears Incorrect Expiration Date
Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.
Product
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1418-2022·2022-07-20
AloePro Aloe Vera Dietary Supplement Recalled Nationwide for Product Spoilage
Premier Research Labs is recalling AloePro Aloe Vera dietary supplement nationwide due to product spoilage visible when opened. Consumers should discontinue use.
Product
AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) PREMIER RESEARCH LABS UPC Code: 80773500137 packaged in plastic HDPW bottles
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·22E060000·2022-07-19
Cummins Recalls BP74E Battery Packs for Transit Bus Fire Risk
Cummins is recalling BP74E battery packs used in transit buses because internal coolant leaks can cause short circuits and increase fire risk.
Product
ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V510000·2022-07-19
Thomas Built Buses Recalling School Buses Due to Seat Frame Cracking
Daimler Trucks North America is recalling 2014-2023 Thomas Built Buses HDX and 2014-2022 EFX school buses because passenger seat frames may crack and rotate.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER EFX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V509000·2022-07-19
2022 Kia Sorento and Telluride recalled for spare tire brake defect
Kia is recalling 2022 Sorento and Telluride vehicles with an incorrect spare tire that can impair the anti-lock braking and traction control systems. These defects increase the risk of a crash.
Product
KIA — KIA SORENTO, TELLURIDE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22E059000·2022-07-18
Besser Pro Recalls Trailer Axles Due to Weld Defects
Besser Pro is recalling 7000 lb Tubular Straight Axle assemblies for trailers because improper welds may cause cracking or separation, increasing crash risk.
Product
EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V507000·2022-07-15
Arcimoto hybrid electric vehicles high voltage connector latch defect
Arcimoto is recalling certain 2019-2022 model year hybrid electric vehicles with a high voltage connector defect that may detach, causing sudden loss of power steering and drive power.
Product
ARCIMOTO — ARCIMOTO ROADSTER, FUV, DELIVERATOR, RAPID RESPONDER
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·021-2022·2022-07-15
Ready Dough Pizza Recalls Pepperoni, Ham, and Bacon Products
Ready Dough Pizza Inc. is recalling approximately 8,018 pounds of pizza products produced without federal inspection and containing undeclared allergens.
Product
Ready Dough Pizza Inc. Recalls Pepperoni Pizza Products Produced Without Benefit of Inspection and also Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·22E058000·2022-07-15
Engineered Controls Recalls Propane Service Valves for Leak Risk
Engineered Controls International is recalling specific propane service valves for recreational vehicles due to incorrect thread depth that may cause leaks.
Product
EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V508000·2022-07-15
Isuzu Recalls 2022 FTR and FVR Trucks Due to Engine Braking Defect
Isuzu is recalling 2022 FTR and FVR trucks because a software error disables engine braking, potentially increasing stopping distances and crash risk.
Product
ISUZU — ISUZU FTR, FVR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V504000·2022-07-14
2022 Chrysler and Dodge vehicles recalled for tire pressure monitoring sensor failure
Chrysler and Dodge are recalling certain 2022 vehicles because TPMS sensors may fail prematurely, causing them to stop alerting drivers to low tire pressure. This can lead to tire failure and increase crash risk.
Product
CHRYSLER — CHRYSLER, DODGE 300, CHARGER, CHALLENGER
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22758·2022-07-14
Westfield Outdoor Recalls Outfitter and Big Horn Tents for Smoke Inhalation Hazard
Westfield Outdoor is recalling approximately 5,050 Cabela's Outfitter and Big Horn camping tents because the stove jack ring can deteriorate under heat and create smoke inside the tent, posing a smoke inhalation risk.
Product
Outfitter and Big Horn tents
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·22E057000·2022-07-14
Chrysler Recalls Mopar Tire Pressure Sensors Due to Battery Failure
Chrysler is recalling Mopar Tire Air Pressure Sensors because the battery may fail prematurely. This can cause the system to stop working, increasing the risk of a crash.
Product
TIRES:PRESSURE MONITORING AND REGULATING SYSTEMS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V505000·2022-07-14
Blue Bird Recalls School Buses Due to Electrical Grounding Defect
Blue Bird is recalling 2018-2022 school buses with Cummins electric drivetrains because an improperly grounded air compressor poses an electric shock risk.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS, VISION, ALL AMERICAN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V506000·2022-07-14
Blue Bird Recalls One 2022 All American Transit Bus for Electrical Defect
Blue Bird is recalling one 2022 All American transit bus because an improperly grounded air compressor can cause electric shock.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22185·2022-07-14
Sakar International Recalls Tony Hawk Silver Helmets Due to Head Injury Risk
Sakar International is recalling about 12,655 Tony Hawk Silver Metallic multi-purpose helmets sold at Walmart from March to June 2022. The helmets do not meet federal safety standards for positional stability and retention, and may fail to protect in a crash.
Product
Tony Hawk Silver Helmets
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1402-2022·2022-07-13
Prairie City Bakery Peanut Butter Chocolate Chip Cakes Recalled for Salmonella
Prairie City Bakery is recalling Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes due to Salmonella contamination from recalled Jif peanut butter ingredient. Products were distributed to gas stations and convenience stores nationwide.
Product
Prairie City Bakery Peanut Butter Chocolate Chip Ooey Gooey Butter Cake 2oz. individual UPC: 7-9788436718-2; 10 individual units per display unit; 6 display units per wholesale case.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1399-2022·2022-07-13
Giant Eagle Cupcakes Recalled Due to Salmonella Contamination Risk
Giant Eagle Cupcakes (GE Cupcake 6 Buckeye, 18Oz) recalled due to potential Salmonella contamination from Jiff Peanut Butter. 14 units distributed to Pennsylvania.
Product
GE 29765500000 Cupcake 6 Buckeye 18Oz
Category
Food
Distribution
1 state
CriticalFDA (Devices)·Z-1319-2022·2022-07-13
Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking
Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.
Product
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1312-2022·2022-07-13
Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk
Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.
Product
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·22V503000·2022-07-13
2022 CAN-AM Ryker Motorcycles: Handlebar Stem Bolt Breakage Recall
CAN-AM is recalling 2022 Ryker motorcycles due to handlebar stem bolts that may break unexpectedly, causing sudden loss of steering control and crash risk.
Product
CAN-AM — CAN-AM RYKER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1388-2022·2022-07-13
Organic oregano ground recalled due to Salmonella contamination
OS Holding Inc is recalling Organic Oregano Ground distributed in Arizona, Minnesota, and Wisconsin due to potential Salmonella leeuwarden contamination.
Product
Organic Oregano Ground is packed in bulk 35 lbs. cases with food-grade poly bag that is labeled in parts: "OREGONSPICE COMPANY***OG Oregano Ground***Net Wt 35 lb (15.89 kg)***13320 NE Jarrett St.*Portland, Oregon 97230***".
Category
Food
Distribution
3 states
SevereFDA (Devices)·Z-1277-2022·2022-07-13
COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly
American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.
Product
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Category
Medical Device
Distribution
1 state
SevereFDA (Food)·F-1395-2022·2022-07-13
Giant Eagle Peanut Butter Fudge Bar Cake Recalled for Salmonella Risk
Giant Eagle is recalling Peanut Butter Fudge Bar Cake made with Jiff Peanut Butter due to potential Salmonella contamination. The affected product was distributed in Pennsylvania.
Product
GE 25022900000 Peanut Butter Fudge Bar Cake 22.6 Oz
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1276-2022·2022-07-13
Clean Catch Urine Kit Recalled Due to Improper Assembly
American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.
Product
Clean Catch Urine Kit NS 178489, AHMU58A
Category
Medical Device
Distribution
1 state
SevereFDA (Food)·F-1411-2022·2022-07-13
Built Bar Banana Cream Pie Puffs Protein Bars Recalled for Potential E. coli Contamination
Built Brands LLC is recalling approximately 4,196 individual Banana Cream Pie Puffs Protein Bars sold nationwide due to potential Escherichia coli contamination.
Product
Built Bar, Banana Cream Pie Puffs Protein Bar, 1.41 oz. (40 g) net wt., packaged in individual wrapper, Built Brands, LLC, 600 E Quality Dr., American Fork, UT 84003. SKU 30000318. Product sold as part of a paperboard 12-count mixed box. Each box contains 4 affected bars. UPC 8…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1175-2022·2022-07-13
CVS Health Magnesium Citrate Laxative Recalled for Bacterial Contamination
CVS Health Magnesium Citrate SALINE LAXATIVE Oral Solution (1.745 g, Lemon Flavor, 10 FL OZ) is being recalled due to microbial contamination with Gluconacetobacter Liquefaciens. Approximately 98,958 bottles distributed nationwide are affected.
Product
CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1318-2022·2022-07-13
Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk
Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.
Product
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1315-2022·2022-07-13
Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect
Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.
Product
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·22V502000·2022-07-13
Van Hool Recalls 2021 TDX25 Motorcoaches Due to Front Axle Weld Defect
Van Hool is recalling 68 2021 TDX25 motorcoaches because front axle welds may crack, potentially causing loss of steering control and increasing crash risk.
Product
VAN HOOL — VAN HOOL TDX25
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1398-2022·2022-07-13
Giant Eagle Chocolate Peanut Butter Cake Recalled for Salmonella Risk
Giant Eagle is recalling chocolate peanut butter iced cakes made with Jiff Peanut Butter due to potential Salmonella contamination. The product was distributed in Pennsylvania.
Product
GE 25136000000 Bakery, Cake, Chocolate, Peanut Butter Iced 8Oz 4
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1391-2022·2022-07-13
Giant Eagle Brownie Tray Classic recalled for potential Salmonella contamination
Giant Eagle's Brownie Tray Classic brownies made with Jiff Peanut Butter are being recalled due to potential Salmonella contamination. The product was distributed in Pennsylvania.
Product
GE 22777900000 Brownie Tray Classic - 24 Ct., 24Oz
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1390-2022·2022-07-13
GE Mini Chocolate Gob with Peanut Butter Icing Recalled for Salmonella
Giant Eagle brand mini chocolate gobs with peanut butter icing are being recalled due to potential Salmonella contamination from Jiff peanut butter used in manufacturing. The product was distributed in Pennsylvania.
Product
GE Bakery, Gob, Mini, Chocolate, Peanut Butter Icing
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1317-2022·2022-07-13
Palindrome H Chronic Catheters Recalled for Potential Hub Leaking
Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.
Product
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide

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