Archive
391 recalls were announced in April 2022.
Of the 391 recalls this month scored against our rubric, 2% are Critical, 17% are Severe.
Which agencies issued them
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Ritedose is recalling 3,795 prefilled syringes of sodium chloride injection nationwide. The barcodes incorrectly identify the product as rocuronium bromide, creating a medication identification risk in healthcare settings.
Sun Pharmaceutical recalls CEQUA cyclosporine ophthalmic solution nationwide due to low assay results and particulate matter found in specific lots.
DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
Prevost is recalling 2018 X3-45 buses because frayed seat belt wires may prevent buckles from working properly, increasing injury risk in crashes.
Prevost is recalling 2021-2022 X3-45 Commuter buses because improperly tightened seat frame bolts may allow seats to move during a crash.
Tesla is recalling certain 2020-2022 Model S, X, Y and 2017-2022 Model 3 vehicles. The Boombox feature can obscure Pedestrian Warning System sounds while driving. A free software update will disable Boombox in Drive, Neutral, and Reverse modes.
Newmar is recalling multiple 2019–2022 RV models due to unsecured wiring beneath seats that can cause electrical short circuits and fire. Owners should contact their dealer for free inspection and repair.
Big Tex Trailer Manufacturing is recalling 2022 50SR and 70SR trailers because improperly welded couplers may cause the trailer to separate from the tow vehicle.
Mercedes-Benz is recalling 21,306 vehicles because a ground cable bolt may not be secured properly, which can cause the electrical cable to overheat and increase the risk of a fire.
Tesla is recalling certain 2021-2022 Model X vehicles due to a defect in the left or right front-row side curtain air bags that may not deploy properly when windows are lowered. Improper deployment increases the risk of injury during crashes.
Columbus Trading-Partners USA is recalling CYBEX Sirona M child seats because loose foam pieces from the headrest pad may pose a choking hazard to children.
Daimler Trucks North America is recalling certain 2020-2022 Western Star 49X and 2021 Western Star 47X vehicles because windshield wiper linkages may break, causing wipers to fail and reducing visibility.
Mercedes-Benz is recalling 126,443 vehicles from 2018-2021 because the rearview camera display may fail to show the rear view due to a software error, reducing visibility and increasing crash risk.
Bestar wall beds can detach from the wall and fall, creating impact and crush hazards. One death and 60 additional injuries have been reported.
Hyundai is recalling 2019 Nexo vehicles because a filter may detach after refueling, causing a hydrogen leak that could lead to fire.
Daimler Trucks North America is recalling certain 2020-2023 Western Star trucks equipped with side air intakes on the hood. The stainless steel cover may loosen and detach, creating a road hazard and increasing crash risk.
CPSC recalls biOrigins sodium hydroxide products sold on Amazon from July 2020 through July 2021 due to non-child-resistant packaging and missing hazard label information. The product poses risk of chemical burns and skin/eye irritation to children.
Stokke is recalling white Clikk high chairs because the plastic seat can break, creating a fall and injury hazard to children. The company has received six reports of seat breakage, including two reports of minor bruises.
Cavendish Farms is recalling Les Fermes Frozen Hash Brown Potato Patties because they contain undeclared wheat and barley flour. People with allergies to wheat or barley should not consume the product.
Multiple brands of yogurt-covered raisins distributed nationwide are being recalled due to undeclared peanuts. Consumers with peanut allergies face a serious health risk.
Jan Fruits, Inc. is recalling Taiwan Best Quality Enoki Mushrooms (UPC 8 51084 00835 8) due to detection of Listeria monocytogenes. The product was distributed in California.
St. Benoit French Vanilla Yogurt is being recalled because it contains undeclared egg, a common allergen. Consumers with egg allergies should not consume the product.
Jubilant Cadista Pharmaceuticals recalls Meclizine Hydrochloride Tablets with incorrect labeling. Bottles labeled as PredniSONE contain Meclizine, risking medication errors.
Prevost is recalling specific alternator belts because a seizing front bearing can cause the belt to overheat, increasing the risk of a fire.
Lamborghini is recalling 2020-2022 Huracan EVO and 2022 Huracan STO vehicles because insufficient transmission oil may cause clutch slippage or fire.
Audi is recalling 2021-2022 R8 vehicles because insufficient transmission oil may cause clutch slippage or fire. Owners should contact dealers for a free inspection.
Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.
Arcimoto is recalling 2019-2022 FUV, Rapid Responder, Deliverator, and Roadster motorcycles. The charging system may disable at freezing temperatures, potentially causing unexpected stalls and increasing crash risk.
2022 Volkswagen Tiguan vehicles are recalled due to insufficient attachment of the rear hatch spoiler. The spoiler may separate from the vehicle, creating a road hazard and increasing crash risk.
Prevost is recalling 6,342 buses from 2010-2023 because a seizing alternator bearing can overheat and cause a fire. Owners will receive free belt replacements.
Audi is recalling 2022 A3 and S3 Sedans because child seat anchorage fitting sleeves are incorrectly marked, which may cause improper child seat installation.
Volkswagen is recalling rear hatch spoilers for 2018-2022 Tiguan long wheel base vehicles because incorrect installation instructions may cause the spoiler to detach.
Volvo Bus is recalling 48 2020 9700 DOT vehicles because a seizing alternator bearing can overheat and cause a fire. Owners will receive replacement belts free of charge.
Good & Gather Dried Sweetened Strawberries are being recalled due to undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.
Carbquik Cinnamon Spice Mug Cakes contain undeclared milk allergen. Approximately 1,700 cases distributed through an Amazon distribution center in New Mexico are affected. Consumers with milk allergies should not consume this product.
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Tam's Homemade Biscuits (Batch No. 015-022) are recalled due to missing allergen statement and ingredient list. Consumers with food allergies cannot identify potential allergens in the product.
Tova Industries is recalling Carbquik Mug Cake Double Chocolate Chunk due to an undeclared milk allergen. Approximately 1,700 cases distributed through an Amazon distribution center in New Mexico are affected.
Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.
Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.
Aurolife Pharma is recalling Glycopyrrolate Tablets after glass fragments were discovered in a sealed bottle from packaging equipment. Approximately 4,080 bottles were distributed nationwide and in Puerto Rico.
Drug Depot (APS Pharmacy) is recalling testosterone cypionate/anastrozole injectable oil due to lack of sterility assurance. The recall affects 846 vials distributed nationwide.
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
Fairmont Foods is recalling Schwan's Spinach & Artichoke Dip because cartons may contain Chicken & Broccoli instead, creating potential allergen risks.
Tova Industries Inc is recalling Carbquik Complete Biscuit and Baking Mix due to undeclared milk allergen. The recall affects 224 cases distributed through an Amazon distribution center in New Mexico.
APS Pharmacy is recalling 73 vials of Testosterone Cypionate/Anastrozole oil due to lack of sterility assurance. The product was distributed nationwide including Puerto Rico.
Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.
Drug Depot's testosterone injection product was recalled nationwide for lack of sterility assurance. Affected consumers should discontinue use and consult their healthcare provider.
Drug Depot recalled 17 vials of Testosterone Cypionate Injectable due to lack of sterility assurance in manufacturing. The recalled product was distributed nationwide and should not be used.
Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect medication effectiveness.
Drug Depot recalls 1,843 vials of Gonadorelin injectable nationwide due to lack of sterility assurance. Patients should consult their healthcare provider regarding previously dispensed doses.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.
Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
Taro Pharmaceuticals recalls Clotrimazole and Betamethasone Dipropionate cream after a stability sample failed potency testing. The recall affects 768 tubes distributed to a retailer in New York, expiring June 2023. No illnesses have been reported.
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
Dr. Reddy's Laboratories is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules (30 mg, 90-count) nationwide due to failed dissolution specifications found during long-term stability testing.
Elmer Candy Corp is recalling Elmer's Pecan Egg candies due to pecan tree bark in the product. The recall affects 370,464 units from lot 2930 distributed in eight states.
Dr. Reddy's Laboratories is recalling 28,068 bottles of Atorvastatin Calcium 80 mg tablets nationwide due to failed impurity and degradation specifications. No illnesses or injuries have been reported.
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. states.
Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.
Jaguar Land Rover is recalling 2016-2017 Range Rover and Range Rover Sport vehicles because the driver's seat belt retractor may not lock during hard braking.
Mercedes-Benz is recalling 2021 S 500 and S 580 vehicles because an improperly secured steering column connector may disable safety features and gear shifts.
Piaggio is recalling 2020-2021 MP3 500 scooters because zinc plating on brake hose fittings may contaminate brake fluid, reducing braking performance and increasing crash risk.
Mercedes-Benz is recalling 2021-2022 Maybach S 580 vehicles because front seat trim parts may detach during rear air bag deployment, potentially causing improper air bag function and injury.
Hyundai is recalling 2020 Accent vehicles with front seat belt pretensioners that may explode during a crash, projecting metal fragments that can strike and injure occupants.
Autocar is recalling 2021-2022 XPEDITOR vehicles because the ABS modulation valve may be wired incorrectly, potentially extending braking distance and increasing crash risk.
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