Archive
857 recalls were announced in June 2022.
Of the 857 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
Medline Industries recalls Polyurethane Foam Bedside Cleaning Kits due to sporadic reports of discoloration on foam sponges caused by microbial contamination. The recall affects 22,765 boxes distributed in the US and Panama.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.
Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.
BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.
Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.
Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.
Karben4 Brewing LLC is recalling 644 cases of Wisco Pop Cherry Soda because the soda may contain yeast. Affected lots 030722.01 and 040822.02 were distributed in Illinois, Minnesota, and Wisconsin.
Karben4 Brewing LLC recalls Wisco Pop Grapefruit Soda (12 FL OZ, UPC 50037-32408) due to possible yeast in cans. The recall includes 411 cases distributed in Illinois, Minnesota, and Wisconsin.
Family Dollar and Johnson & Johnson Consumer are recalling Aveeno Daily Moisturizing Lotion due to cGMP violations involving improper storage temperature. No illnesses have been reported.
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.
Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.
Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses reported.
Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.
Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.
Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.
Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.
Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.
MEDLINE has recalled certain lots of its Polyurethane Foam Bedside Cleaning Kit due to microbial contamination detected on the foam sponge. Sporadic reports of discoloration were identified as contamination.
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.
Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.
C.E. Smith is recalling 2021-2022 boat trailers because a weld may fail, causing the wheel to separate and increasing crash risk.
Volvo Trucks North America is recalling 2022-2023 VN tractor trailers because incorrectly assembled steering gears may fracture, increasing crash risk.
Off Grid Trailers is recalling 2021-2022 Expedition, Pando, and Switchback travel trailers because damaged burner control valves may cause a gas leak.
Kawasaki is recalling 2020-2022 LX230 motorcycles because an incorrect front brake rotor may have been installed, reducing brake performance and increasing crash risk.
Mack Trucks is recalling certain 2021-2022 tractor trailers due to steering gears that may fracture, causing loss of steering control and crash risk.
Clek is recalling Olli and Ozzi booster seats because a required installation diagram is missing, which could lead to improper installation and increased injury risk in a crash.
Forest River is recalling 2022 East to West Alta and Palomino SolAire travel trailers because incomplete welds on the swing-up table base may cause it to drop unexpectedly, increasing injury risk.
Micro Bird is recalling 2017-2018 G5 school buses because an incorrect bracket may interfere with the driver's seat belt pretensioner, increasing injury risk in a crash.
Daimler Trucks North America is recalling 2023 Freightliner Business Class M2 trucks due to a u-joint pinch bolt that may detach from the steering shaft, causing loss of steering control and increasing crash risk.
Goodyear is recalling specific G159 tires because the tread may separate, increasing the risk of a crash. Owners should contact dealers for free replacement.
Backcountry Access Tracker4 Avalanche Transceivers are being recalled because the toggle switch can separate from the unit and prevent it from switching to search mode, which could prevent rescuers from locating a buried skier.
Joey Clothing is recalling about 15,930 children's robes sold online because they fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries.
Demdaco microwavable bowl holders can char and catch fire when microwaved for the recommended time. The company received three reports of charring incidents and is offering refunds.
Electrolux is recalling about 367,500 Frigidaire and Electrolux refrigerators because the ice level detector arm in the ice maker can break apart and fall into the ice bucket, creating a choking hazard.
Target is recalling about 120,000 children's pajama sets because they fail to meet federal flammability standards for sleepwear, posing a burn injury risk to children. Consumers should return the pajamas to Target for a full refund.
Communicorp is recalling about 600,000 six-inch Aflac plush promotional ducks distributed to Aflac employees and customers from February 2009 through March 2021. The ducks contain phthalates and lead levels that exceed federal standards and pose a risk if ingested by young children.
Winnebago is recalling 2020 ERA motorhomes because damaged burner control valves may cause a gas leak, increasing the risk of fire.
Asweets is recalling about 13,300 Wonder & Wise baby activity walkers because rubber rings on the rear wheels can detach, posing a strangulation hazard to young children. No injuries have been reported.
General Motors is recalling certain 2022 Cadillac XT6 vehicles because the brake fluid reservoir cap may be missing its required warning label. Without the label, brake fluid could become contaminated with debris, affecting brake performance.
Sunomono Vinegar in 5-gallon jugs is recalled due to undeclared soy and wheat allergens. Consumers with allergies should avoid this product.
Benzonatate 100mg capsule bottles are mislabeled. Some contain Benzphetamine tablets instead, and vice versa. This medication mix-up affects 10 bottles distributed to one physician in Alpharetta, Georgia.
Joonsung Trading Inc is recalling Spicy Chicken Sauce in 1/2 gallon plastic jugs because the product contains wheat but the label does not declare it. This poses a serious risk to consumers with wheat allergies.
The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.
Damascus Bakery LLC is recalling Bantam Bagels Everybody's Favorite Everything Bagels due to undeclared egg allergen. The affected product was distributed to a consignee in Georgia.
Joonsung Trading Inc recalls Champon Soup Base due to undeclared milk and tuna allergens. Affected 32 oz containers were distributed in Oregon and Washington; products dated before April 14, 2022 are recalled.
Joonsung Trading Inc recalls Mio Salad Dressing due to undeclared egg allergen. The label lists Mayo but fails to declare Egg, creating serious risk for egg-allergic consumers.
Joonsung Trading Inc is recalling Chirashi Sauce in 1/2 gallon jugs because the label fails to declare soy and wheat allergens present in the product.
Hippie Organics French Beans, 1Lb packages (Lot IM313626) are recalled due to potential Listeria monocytogenes contamination. Alpine Fresh, Inc. notified the FDA after a positive test result.
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
Olympia Compounding Pharmacy is recalling 7,420 vials of Preserved Ascorbic Acid due to lack of assurance of sterility. The injectable drug was distributed nationwide throughout the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 482 vials of RE-1 (Papaverine, Phentolamine, Alprostadil) injectable medication due to lack of sterility assurance. Product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.
Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.
Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.
Olympia Pharmacy is recalling 588 vials of Sodium Tetradecyl Sulfate 5% injection nationwide due to inability to assure product sterility. The multi-dose vials carry a potential contamination risk for patients.
Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.
Olympia Compounding Pharmacy is recalling Sermorelin Acetate injectable powder because of insufficient assurance of sterility. Patients using affected lots should contact their healthcare provider.
Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.
Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.
Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.
Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.
Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.
Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.
International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.
Smith & Nephew is recalling INTERTAN 1.5 nails because right nails were marked and labeled as left nails, and vice versa. This mislabeling could lead to incorrect surgical placement.
Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.
Elgin Sweeper is recalling 2018-2022 RegenX vehicles because improperly tightened fan assembly bolts may detach, creating a road hazard and increasing crash risk.
Dalton Enterprises is recalling 2021-2022 Adam J2040 horse trailers because damaged burner control valves may cause a gas leak, increasing fire risk.
RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.
Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.
Olympia Compounding Pharmacy is recalling Lipostat-Plus vials nationwide due to lack of sterility assurance. Approximately 4,843 vials were distributed across the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Formula F1, a compounded injectable medication, due to lack of sterility assurance. The 1,703 vials were distributed nationwide.
Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.
Olympia Compounding Pharmacy is recalling T-105 Papaverine injection vials due to lack of assurance of sterility. The recall affects 3,312 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling Amino Blend injectable vials due to lack of assurance of sterility. Approximately 7,761 vials were distributed nationwide. The FDA has classified this as a Class II recall.
Olympia Compounding Pharmacy is recalling 2,260 vials of Tri-Immune Boost injectable supplement due to lack of sterility assurance. Distribution was nationwide, including Puerto Rico and US Virgin Islands.
Cole's Select Curry Salmon Rice Bowl is being recalled because salmon and soy ingredients are not declared on the label. Consumers with allergies to salmon or soy should not consume this product.
Mrs. Miller's Homemade Jam Smokey BBQ Bacon Jam is being recalled because the label does not declare soy allergen. 5,315 cases were distributed across 15 states.
HEB Bakery Simply Delicious Cookies with Brownie Bites Party Tray (UPC 041220488988, Lot 22063 07:08) is being recalled due to potential metal fragments in the product distributed in Texas.
Olympia Compounding Pharmacy recalls T-106 injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy recalls 2,333 vials of Sodium Selenite 200 mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
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