Archive
561 recalls were announced in July 2022.
Of the 561 recalls this month scored against our rubric, 1% are Critical, 17% are Severe.
Which agencies issued them
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.
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
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.
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.
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.
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.
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.
Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.
Wright Medical recalls 231 EVOLVE TRIAD Plate Cutters due to sterilization failure when double-wrapped. The devices cannot be adequately sterilized, creating infection risk during surgical procedures.
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.
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.
Zeltiq Aesthetics is voluntarily discontinuing the CoolFit ZELTIQ Vacuum Applicator due to an increased complaint rate for the adverse event Paradoxical Hyperplasia observed during 2019-2021.
Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.
Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.
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.
MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.
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.
Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.
Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
Philips DigitalDiagnost C90 radiography systems have a firmware defect that may cause incorrect radiation doses and anatomic marker misalignment. The issue affects 140 systems nationwide with specific serial numbers.
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.
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
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.
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.
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
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.
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.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
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.
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.
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.
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.
Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.
Tailor Made Compounding is recalling 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 2022.
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.
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (5 mL and 10 mL) due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates were distributed nationwide in the USA and Puerto Rico.
Testosterone propionate injectable vials are being recalled due to lack of assurance of sterility. The recall affects product distributed nationwide in the USA and Puerto Rico.
TMC Acquisition LLC is recalling Calcium Chloride Preservative Free injectable solution in 5 mL and 30 mL vials due to lack of assurance of sterility. The recall affects 138 vials distributed nationwide.
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.
CVS Hydrogen Peroxide Topical Solution bottles contain 70% isopropyl alcohol instead of the labeled hydrogen peroxide. The labeling error could lead to misuse and potential harm if consumers use the product as labeled.
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.
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.
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.
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.
Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.
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.
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.
Certain Philips DigitalDiagnost C90 X-ray systems contain a firmware defect that can cause incorrect radiation doses and misaligned anatomic position markers when using the Wallstand VS2 board.
Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.
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.
Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.
Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.
Cordis is recalling 1,089 units of PALMAZ GENESIS Transhepatic Biliary Stents due to potential stent dislodgement in two specific device sizes. Affected patients should contact their healthcare provider.
SCIENCE & BIO MATERIALS has recalled ComposiTCP 30 Interference screws due to mislabeling. The recall affects 72 units distributed nationwide in the US.
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.
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.
Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.
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.
Zeltiq Aesthetics is removing 703 CoolCurve ZELTIQ vacuum applicators due to increased complaints of Paradoxical Hyperplasia reported between 2019 and 2021.
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.
Premier Research Labs is recalling AloePro Aloe Vera dietary supplement nationwide due to product spoilage visible when opened. Consumers should discontinue use.
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.
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.
Cummins is recalling BP74E battery packs used in transit buses because internal coolant leaks can cause short circuits and increase fire risk.
Besser Pro is recalling 7000 lb Tubular Straight Axle assemblies for trailers because improper welds may cause cracking or separation, increasing crash risk.
Engineered Controls International is recalling specific propane service valves for recreational vehicles due to incorrect thread depth that may cause leaks.
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.
Isuzu is recalling 2022 FTR and FVR trucks because a software error disables engine braking, potentially increasing stopping distances and crash risk.
Ready Dough Pizza Inc. is recalling approximately 8,018 pounds of pizza products produced without federal inspection and containing undeclared allergens.
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.
Blue Bird is recalling one 2022 All American transit bus because an improperly grounded air compressor can cause electric shock.
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.
Blue Bird is recalling 2018-2022 school buses with Cummins electric drivetrains because an improperly grounded air compressor poses an electric shock 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.
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.
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.
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.
Giant Eagle Cupcakes (GE Cupcake 6 Buckeye, 18Oz) recalled due to potential Salmonella contamination from Jiff Peanut Butter. 14 units distributed to Pennsylvania.
Built Brands LLC is recalling approximately 4,196 individual Banana Cream Pie Puffs Protein Bars sold nationwide due to potential Escherichia coli contamination.
Van Hool is recalling 68 2021 TDX25 motorcoaches because front axle welds may crack, potentially causing loss of steering control and increasing crash risk.
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.
The 2022 Toyota Tundra with Panoramic View Monitor may display front camera footage instead of rear camera when in reverse, reducing rear visibility and increasing crash risk. Toyota will reprogram the parking assist system free of charge.
OS Holding Inc is recalling Organic Oregano Ground distributed in Arizona, Minnesota, and Wisconsin due to potential Salmonella leeuwarden contamination.
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.
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.
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.
Giant Eagle's Peanut Butter Fudge Split Cake, made with Jiff Peanut Butter, is being recalled due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania.
Pure Ground Ingredients has recalled specific lots of organic oregano leaf powder and ground oregano sold in Oregon, Wisconsin, Maryland, and Colorado due to potential Salmonella contamination.
Giant Eagle is recalling a 16-ounce Peanut Butter Creme Brownie made with Jiff Peanut Butter due to potential Salmonella contamination. The product was distributed to Pennsylvania.
Giant Eagle's GE Bakery peanut butter thumbprint cookies are recalled due to potential Salmonella contamination from Jiff peanut butter. The 12-ounce packages distributed in Pennsylvania should not be consumed.
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.
Giant Eagle Torte Peanut Butter (62 oz, code GE 23984200000) is recalled due to potential Salmonella contamination from the Jiff peanut butter ingredient. Consumers should not consume this product.
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.
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