Archive
754 recalls were announced in May 2023.
Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.
Which agencies issued them
Cargill is recalling approximately 110,650 pounds of PROSANTE TVGPTN 12B products labeled as gluten-free because they may contain gluten above the safe threshold.
The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.
Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.
Cargill recalls 977,000 pounds of soy flour products labeled gluten-free that may contain gluten above FDA limits. Products were distributed in the US and multiple countries.
Cargill is recalling 36,000 lbs of grain products labeled as gluten-free that may contain gluten above the FDA safety limit. Consumers with celiac disease or gluten sensitivity should not consume affected product code 110026470-02523CHXEA.
Linkbio Corp. is updating labeling and surgical technique training for the LINK SLED Knee System to prevent early aseptic loosening or excessive wear caused by improper implant positioning or inadequate cementing during surgery.
Cargill is recalling PROSANTE soybean flour products that may contain gluten levels exceeding 20 ppm despite gluten-free labeling. Approximately 826,150 pounds were distributed nationwide and internationally.
Pool Forge Dairy is recalling White Cheese Queso Blanco due to possible pathogen contamination from inadequate pasteurization. The product was distributed in New Jersey with sell-by dates from January 7 to March 28, 2023.
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.
Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.
Bakery 37 Inc recalls Blue Moon Bakery Ginger Molasses Breakfast Cookies (3oz) distributed in Oregon due to sesame declared in ingredients but not in the allergen Contains statement. Affected manufacturing dates: January 1 to March 22, 2023.
Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.
PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.
Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.
Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.
Cargill is recalling PROSANTE soyflour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's threshold for gluten-free claims. People with celiac disease or gluten sensitivity should not consume these products.
ASO LLC is recalling Walgreens assorted bandages (item 196568) distributed nationwide due to benzalkonium chloride in the adhesive pad that is not disclosed on the labeling.
Cargill recalls 174,600 lbs of bulk ingredient distributed nationwide and internationally. Products labeled gluten-free contain gluten levels exceeding 20 ppm.
GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.
Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.
Cargill is recalling PROSANTE vegetable protein products labeled gluten-free due to potential gluten contamination exceeding 20 ppm. Consumers should check product codes and discard or return affected items.
Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.
Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.
Blue Moon Bakery Choconut Breakfast Cookie is being recalled because sesame is not listed in the Contains statement on the label, despite being present in the product. Consumers allergic to sesame may consume the product unknowingly.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.
Bakery 37 Inc is recalling Blue Moon Bakery Legendary Breakfast Cookies because they contain undeclared sesame. The cookies were distributed in Oregon and may pose a risk to consumers with sesame allergies.
Cargill is recalling PROSANTE soy flour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's regulatory threshold for gluten-free labeling. Products were distributed nationwide and internationally.
FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.
OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.
Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.
Cargill is recalling Prosante TVGPTN food products labeled as gluten-free that may contain gluten above 20 ppm.
Cargill is recalling PROSANTE TVGPTN 3018B FLK poultry ingredient because products labeled gluten-free may contain gluten levels above 20 ppm, the legal threshold for gluten-free claims.
Weleda Inc is recalling Hepatodoron® tablets due to potential metal contamination. The affected batch (J033, expiring January 31, 2027) was distributed nationwide.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
Give & Go Prepared Foods is recalling H-E-B Bakery Two-Bite Brownies due to potential soft rubber fragments that could pose a choking hazard. The recall affects 3,607 cases distributed in Texas.
PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.
20-100 Delicious Seasoning LLC recalls Sofrito Marinating Sauce because the product was not stored refrigerated as required. Consumers should not consume the product.
PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.
Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
Simply Good Foods is recalling Atkins Milk Chocolate Delight Protein Shakes nationwide due to post-processing contamination that may cause spoilage. Affected products have lot numbers SA2208P3F6 (exp. 07/27/23) or SA2210P3F6 (exp. 07/29/23).
Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
Signature Select Nuts & Grain Bread may contain undeclared tree nuts from potential cross contamination. The product is distributed in Western U.S. states and poses a risk to consumers with tree nut allergies.
Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.
Albertsons Companies LLC is recalling Signature Select Oat & Nuts Bread (20 oz) due to potential undeclared tree nut allergens from cross-contamination. Consumers with tree nut allergies should not consume affected products.
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.
Novis PR, LLC is recalling PreProtein Liquid Predigested Protein dietary supplement because certain bottles are bloated. The recall affects approximately 4,106 units from lot 230118.
Braun is recalling 2019-2023 ambulances because suspension systems may wear brake lines, risking rear brake loss and crashes.
Daimler Trucks North America is recalling Thomas Built school buses due to potentially insufficient rear interior joint strength. Dealers will add fasteners to reinforce the joints at no charge.
E-One is recalling 2022-2023 Cyclone N and Typhoon N vehicles because the aerial device sensor may fail, risking operator injury.
Advance Stores Company is recalling specific Carquest lower ball joints that may separate from the steering knuckle, potentially causing a loss of steering control.
Triple E is recalling 2023 Unity and Wonder motorhomes because exposed copper at the GFCI exterior receptacle can cause electrical shorts, arcing, and fire.
Ferrari is recalling 2022-2023 296 vehicles because a fuel tank pipe may corrode and leak, increasing fire risk. Owners should not drive until repaired.
Daimler Trucks North America is recalling 2024 Thomas Built SAF-T-LINER C2 school buses because a rear exterior joint may have insufficient strength, increasing injury risk in a crash.
Airstream is recalling 2023 Atlas motorhomes due to undersized fuses that may allow wiring to overheat and increase fire risk. Dealers will replace the fuse and install a new circuit.
Continental Automotive Systems is recalling specific Electric Brake System modules where manufacturing defects may cause internal leaks, potentially increasing crash risk.
Jayco is recalling 2022 Esteem, Odyssey, Redhawk, and Greyhawk motorhomes because fuel tank paint may peel, causing corrosion and potential fuel leaks.
Navistar is recalling 49 2023 International MV trucks because the driveshaft tube seam weld may separate or tear, causing sudden loss of drive power and increasing crash risk.
Polaris is recalling about 14,885 Model Year 2022-2023 MATRYX RMK KHAOS and PRO snowmobiles. When the rider engages the throttle and brake simultaneously, the brake system can overheat, posing a fire hazard and risk of burn injuries.
Custom Fire is recalling two 2023 Spartan Metrostar RT fire trucks because a transmission defect may cause unexpected movement and prevent the water pump from operating.
Jayco is recalling 2024 Entegra Vision and related motorhomes due to rear brake caliper attachment bolts that may not be properly tightened. Loose bolts could damage the wheel or brake lines, reducing brake performance and increasing crash risk.
Outback Customs is recalling 2018-2020 Elite and Cimarron horse trailers because a gas leak from the stove may increase fire risk.
About 570 Ricky Powersports youth ATVs fail to meet federal safety standards, including parking brake and labeling requirements. The defects pose a risk of serious injury or death.
Walker Edison Furniture is recalling about 121,000 Twin Over Twin Bunk Beds because the wooden slats supporting the beds can break while in use, posing fall and impact hazards. The company has received 14 incident reports, including one report of minor injuries.
Culture Fly is recalling approximately 6,600 L.O.L. Surprise! Trick or Treat subscription boxes sold with metal doll pins because the paint on the pins contains lead levels that exceed the federal lead paint ban, posing a lead poisoning hazard to young children.
The Company Store is recalling about 930 children's white robes sold online from September 2021 through November 2022 because they fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk.
Altec is recalling 2017-2022 Digger Derricks because missing hardware may allow the auger extension bar to detach, increasing injury risk.
Outback Customs is recalling certain 2020-2023 horse trailers and 2021-2022 Sprinter Vans equipped with SDS2 cooktops. Aluminum burner tubes may fracture and leak gas, increasing fire risk.
Ferrara Fire Apparatus is recalling 2022 Ultra and Inferno fire trucks because water in the winch remote can cause corrosion and unintentional operation.
PJ Trailers is recalling certain 2022-2024 trailers with Demco EZ Latch Gooseneck Couplers because the mounting bolts may loosen, causing the coupler to separate and creating a crash risk.
Jaguar Land Rover is recalling 2022-2023 Range Rover vehicles because the second-row armrest latch may fail, allowing unsecured objects to strike occupants during a crash. Dealers will replace the locking arm free of charge.
Baby Trend is recalling approximately 2,600 Hybrid 3-in-1 Combination Booster Seats because the latch assembly webbing may fray, potentially failing to restrain a child in a crash.
Jayco, Inc. is recalling certain 2021-2024 Class B recreational vehicles. A fuel hose clamp may be inadequate, potentially causing gasoline leaks and increasing fire risk.
Berkshire Innovations is recalling about 990 Sahara Folding Food Dehydrators because the heater fan can fail and cause the unit to overheat, posing a fire hazard. No injuries or property damage have been reported.
ODL Inc. is recalling Severe Weather Doorglass Inserts sold at Home Depot and Lowe's because the adhesive bond can separate during hurricanes, creating a risk of injury and property damage from windborne debris.
Savor Imports IQF Whole Raspberries (Lot 20220210) are recalled nationwide due to potential Hepatitis A contamination. Consumers should not eat the product and should return or discard it.
Bentley is recalling 2021-2023 Flying Spur vehicles because an incorrectly installed rear entertainment screen bracket could become a projectile in a crash, increasing injury risk.
Lamb Weston Sales is recalling frozen hash brown patties due to undeclared wheat allergen. The recall affects approximately 1605 cases distributed to foodservice customers across multiple states and international locations.
Fresh Express is recalling Premium Makoto Honey Ginger Salad Kits distributed in five states because the product tested positive for Listeria monocytogenes. Consumers should not consume this product.
Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce has been recalled due to testing positive for Listeria monocytogenes. The affected product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.
Fresh Express Chopped Kit Chipotle Cheddar salad has been recalled because it tested positive for Listeria monocytogenes. The product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.
Patagonia Foods is recalling frozen blackberries (Lot 20422) distributed in six U.S. states due to possible Hepatitis A contamination. Consumers should not consume the product.
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.
Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.
Our Family White Hot Dog Enriched Buns are being recalled due to undeclared sesame. The recall affects approximately 28,700 units distributed in Michigan, Ohio, Indiana, and Illinois, and poses a risk to consumers with sesame allergies.
Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.
Looking for a different month? Back to 2023.