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
Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in Missouri.
Duke's Southern Sauces Bayou Remoulade sauce is mislabeled as gluten-free but contains wheat in its soy sauce ingredient. Consumers relying on the false gluten-free label could be harmed.
Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.
Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.
Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.
The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.
Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.
Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.
Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.
Winnebago and Itasca recall certain 2020-2023 motorhomes due to improperly tightened seat belt attachments that may fail to restrain occupants in a crash. Dealers will tighten fasteners free of charge.
Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.
Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. No illnesses have been reported.
Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.
3M is recalling 3M Attest Steam Chemical Integrators manufactured November 2022–January 2023 due to increased potential for ink leakage during sterilization cycles. Approximately 16.2 million units were distributed worldwide.
Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.
Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.
240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.
Astral SteriTech has recalled Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. The recall affects 6,127 bottles.
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.
Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.
Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.
Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was distributed nationwide.
Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.
Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.
Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.
Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.
Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.
Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.
Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.
The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.
Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.
REAL GREEK LLC is recalling Ellenos Vanilla Bean Greek Yogurt 4oz cups due to mislabeling: Lemon Curd yogurt was packaged as Vanilla Bean, and egg is not declared on the label.
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.
Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.
Xellia Pharmaceuticals is recalling 739,750 vials of Ceftriaxone for Injection, USP due to lack of assurance of sterility. All affected lots nationwide should not be used.
Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.
Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.
Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.
Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.
RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.
Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.
Steris is recalling 322 Reliance Vision Multi-Chamber Washer/Disinfectors because an electrical contactor malfunction could cause heating elements to overheat and produce smoke or fire.
The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.
RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.
3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.
Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.
Philips is recalling 25 CombiDiagnost R90 R1.1 diagnostic imaging systems nationwide due to missing FDA certification labels required for regulatory compliance.
Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.
Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.
Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.
Origami Catering's Wakame Seaweed Salad is recalled because wheat is present but not declared in the allergen statement. Affected product: 4.5oz packages, UPC 8 51016 00235 5, distributed in Oregon and Washington.
Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.
Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.
Polestar is recalling 2020-2021 Polestar 1 vehicles because defective high-voltage battery cells may overheat and cause a fire. Dealers will replace the battery pack free of charge.
Nissan is recalling 2023 Leaf vehicles because the right-hand brake tube may corrode and leak fluid, potentially reducing braking performance.
Sofina Foods is recalling ready-to-eat mortadella deli meat products because they may contain undeclared pistachios, a known allergen.
Mercedes-Benz is recalling 7,558 vehicles because a software malfunction may disable critical safety systems like ABS and stability control, increasing crash risk.
SEA Electric is recalling 84 SD120A drivetrain conversion kits for Hino 195 vehicles because vibration may crack the traction motor mount, increasing crash risk.
Forest River is recalling 2023 Salem and Wildwood travel trailers due to missing thread sealant on furnace fittings. The defect can cause propane gas leaks, increasing fire risk.
Polaris is recalling about 20,330 Model Year 2021–2023 RZR Pro XP 4 and Model Year 2022–2023 RZR Turbo R 4 recreational off-road vehicles because a fuel leak at the fuel pump assembly can occur near a hot surface, posing a fire hazard. The company has received five reports of fuel leaks, including one report of fire.
The CPSC is warning consumers to stop using BQQZHZ combination smoke and carbon monoxide detectors immediately because they can fail to alert to hazardous smoke and fire. About 25,000 units sold on Amazon.com are affected.
About 456,000 PowerXL Stuffed Wafflizer waffle makers are being recalled because hot pieces of waffle or stuffing can be expelled during use or when opening the product, creating a burn risk. The firm has received 44 incident reports, including 34 burn injuries with three requiring medical attention.
Target is recalling approximately 4.9 million Threshold Glass Jar Candles because the glass jar can crack or break during use, posing laceration and burn hazards. Six injuries, including lacerations and severe burns, have been reported.
Terminal Investment Corporation is recalling 2022-2023 Tico Spotter B 6.7 trucks because incorrectly assembled steering gears may fracture, causing loss of steering control.
Ford is recalling certain 2021-2023 Bronco vehicles because first-row seat belt latch plates may be difficult to access, potentially preventing occupants from wearing their seat belts and increasing crash injury risk.
Gillig is recalling 2022 Low Floor CNG transit buses because an electrical failure in the fuse box may cause a short-circuit, increasing the risk of a fire.
Altec is recalling 2021-2023 aerial devices, digger derricks, and related equipment because water can leak into strobe lights, causing electrical short-circuits that increase fire risk. No injuries have been reported.
Certain 2021–2023 Jeep Grand Cherokee models have an incorrectly assembled steering column intermediate shaft that may disconnect and cause loss of steering control, increasing crash risk. Chrysler is offering free inspection and replacement.
Acme United is recalling PhysiciansCare Allergy, Allergy Plus, and Cold and Cough tablets sold on Amazon.com from January 2021 through August 2022 because the packaging is not child resistant, risking poisoning if young children swallow the contents.
VinFast is recalling 2023 VF 8 vehicles because a software error may cause the main display to go blank, hiding critical safety information like the speedometer.
Navistar is recalling certain International trucks (2000-2024 model years) for inadequate back-up light visibility when reversing. Low visibility may not alert other drivers, increasing crash risk. Dealers will replace rear stop/turn signal lights free of charge.
Messingschlager USA LLC (Cycle Force) is recalling about 1,750 Ventura Adult Bike Helmets because they do not meet federal safety standards for positional stability and can fail to protect in a crash. No injuries have been reported.
REV Recreation Group is recalling 2020-2024 Fleetwood Bounder, Holiday Rambler Vacationer, and select Fleetwood Southwind motorhomes. The trailer hitch may become damaged due to stress or overloading, potentially causing the towed vehicle to separate.
Looking for a different month? Back to 2023.