Archive
482 recalls were announced in August 2021.
Of the 482 recalls this month scored against our rubric, 2% are Critical, 26% are Severe.
Which agencies issued them
KTM is recalling 2022 Husqvarna FE 350S and FE 501S motorcycles because incorrectly mounted brake pad clips may cause loose front brake pads, reducing braking performance.
Autocar is recalling 2021 Xpeditor and certain 2020-2021 Legend vehicles due to a power steering pump defect that can cause loss of power steering assist and increase crash risk.
Utility Trailer is recalling 2022 VS2RA trailers because incorrect tape on the top foil may cause the sealer plate to separate from the roof, creating a road hazard.
Takata is recalling specific non-azide driver-side air bag inflators that may absorb moisture, potentially causing the inflator to explode or the air bag to underinflate during deployment.
Triple E RV is recalling 550 Unity and Wonder vehicles because a 12-volt wire near the refrigerator exhaust could melt and cause a fire.
Subaru is recalling 2021 Impreza vehicles because the left-front lower control arm weld may fail, causing the arm to separate. This could result in loss of vehicle control and increased crash risk.
Vermeer is recalling 2021 BC900XL, BC1000XL, and BC1200XL brush chippers because the discharge chute may separate and fall off the trailer, creating a road hazard.
Bolt Custom Trucks is recalling 340 Custom Sleepers from 2018-2021 because window adhesive may fail, causing the vent to detach and increasing crash risk.
Fratelli Beretta USA is recalling approximately 862,000 pounds of ready-to-eat uncured antipasto meat products due to possible Salmonella contamination.
Cooper Tire is recalling specific Hercules Roadtour 455 Sport tires due to a manufacturing issue that may cause belt separation, increasing the risk of a crash.
Boise Mobile Equipment is recalling one 2016 Type 3 fire truck because its LED lights may be too bright, potentially affecting other drivers' vision and increasing crash risk.
KZRV is recalling 2018-2022 recreational vehicles with defective Winntec propane regulators that may fail and increase pressure, raising the risk of fire.
Cooper Tire is recalling specific Evolution H/T tires marked with the wrong manufacture date, which could lead to use beyond their recommended service life.
Airstream is recalling certain 2021 recreational vehicles with propane regulator defects that can increase pressure and enlarge flames in gas appliances, creating a fire risk. Dealers will replace the regulator and test the system at no cost.
Coach House is recalling 2019-2022 Platinum II and 2022 Platinum recreational vehicles due to window adhesive failure. The adhesive bonding the window vent may fail, potentially causing detachment and increasing crash or injury risk.
Escape Trailer is recalling 2019 recreational trailers because window adhesive may fail, causing the vent to detach and increasing crash risk.
Chrysler is recalling 2020 Jeep Wrangler vehicles with 2.0-liter engines because a cracked fuel supply line connector may leak fuel, increasing fire risk.
2021 Dodge Challenger vehicles may not properly illuminate safety system status indicators in daylight or nighttime conditions. This could prevent drivers from knowing the status of vehicle safety systems, increasing crash risk.
Space Craft is recalling 2019-2021 travel, fifth-wheel, and semi-trailers because window vent adhesive may fail, posing a crash or injury risk.
Jaguar is recalling 2020-2022 F-Pace, XF, and F-Type vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Land Rover is recalling certain 2020-2022 vehicles because the seat belt automatic locking retractors may deactivate early, preventing child restraint systems from securing properly. This can increase the risk of injury during a crash.
Ryan and Rose is recalling Cutie Spoovel children's eating utensils because the handle can break off when bitten, releasing small parts that pose a choking hazard to young children. No injuries or choking incidents have been reported.
Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX transit buses because the power steering hose may be routed with inadequate clearance, potentially causing damage and increasing fire risk.
Mane Inc is recalling Flavored Bacon Ranch Seasoning packaged in 25lb kraft paper bags due to Salmonella detected in an ingredient used during manufacturing. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.
Able Groupe Inc is recalling Holle Bio Stage 2 Organic Follow-On Infant Milk Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English required by federal regulations.
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Key Safety Systems (DBA Joyson) is recalling specific HPH-A curtain air bag inflators because moisture-induced corrosion can cause the inflator to rupture, potentially sending fragments into the vehicle cabin.
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
Mane Inc is recalling Sweet & Smoky BBQ seasoning packaged in 50lb kraft paper bags because an ingredient tested positive for Salmonella. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Rigid Hitch is recalling certain DHB-series tow hitches because incorrect welding settings may cause the weld to fail, increasing the risk of a crash.
Able Groupe Inc is recalling HiPP Dutch Stage 1 Combiotic Infant Milk Formula because it was not approved by the FDA and may contain insufficient iron for vulnerable infants, particularly those born prematurely or with low birth weight.
Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.
Ballreich Snack Food Company is recalling Barbeque Marcelled Potato Chips in 1.5, 2.5, and 7 ounce packages due to possible Salmonella contamination from an ingredient. The affected products were distributed in Indiana, Michigan, and Ohio.
Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula because required FDA pre-market notifications were not submitted. Some units contain inadequate iron levels and lack required English labeling.
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.
Able Groupe Inc is recalling Holle Bio Stage PRE Organic Infant Milk Formula because the products were not submitted for FDA pre-market approval, contain potentially inadequate iron levels, and lack required labeling in English.
Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.
Able Groupe Inc is recalling Kendamil Organic Stage 1 First Infant Milk Formula because required pre-market FDA notifications were not submitted and the product lacks mandatory English labeling statements.
Mane Inc is recalling BBQ seasoning products because an ingredient tested positive for Salmonella. The recall affects seasoning distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.
Deking Corporation is recalling Winntec and WIC Model 6020 LP regulators installed in recreational vehicles. The parts may fail and cause excessive gas pressure, increasing the risk of fire.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Able Groupe Inc is recalling Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula because some products contain insufficient iron and lack required FDA labeling. The formula may not provide adequate iron for certain infants, including premature infants and those with low birth weight.
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Daimler Trucks North America is recalling 2022 Thomas Built Buses Minotour school buses because adhesive may not have been properly applied, resulting in insufficient joint strength.
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
Summit Trailer Sales is recalling one 2017 AD45 trailer because the steering arm may detach, potentially causing loss of steering control or a road hazard.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Daimler Trucks North America is recalling 2016-2021 Thomas Built Buses Saf-T-Liner HDX school buses because a power steering hose may be routed with inadequate clearance, increasing the risk of a fire.
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.
Able Groupe Inc is recalling Lebenswert Folgemilch Stage 3 Organic Toddler Formula because required FDA pre-market notifications were not submitted and the product lacks mandatory labeling in English as required by federal regulations.
Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.
Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.
W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.
Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.
Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.
NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.
OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.
Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling required by federal regulations.
CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.
Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.
Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.
Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.
Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.
Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.
Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.
Able Groupe Inc is recalling Holle Goat Stage 1 Organic Infant Milk Formula because required FDA pre-market notifications were not submitted and products lack mandatory labeling statements in English.
Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.
Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.
Boston Scientific is recalling TheraSphere Administration Sets due to potential for leaks and loosening at the patient catheter connection. The recall affects 4980 sets distributed worldwide.
Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.
The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.
Razor USA is recalling about 237,300 Hovertrax 2.0 self-balancing hoverboards with GLW lithium-ion battery packs that can overheat and catch fire or explode. More than 20 reports of overheating, smoke, or fire have been received, though no injuries have been reported.
Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.
Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.
Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.
Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.
Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.
Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.
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