Archive
423 recalls were announced in September 2023.
Of the 423 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.
Which agencies issued them
Stonewall Kitchen brand Peanut Butter Maltballs (6oz) may contain undeclared peanut, soy, and wheat. Consumers with allergies to these ingredients should not consume this product.
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
Moore Family Farms and Creamery Cheddar Cheese Curds (1 lb plastic bags) are being recalled due to potential contamination with elevated coliform counts and E. coli. The recall affects 30 bags distributed in Iowa.
Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Daimler Trucks North America is recalling 679 2024 Thomas Built Buses SAF-T-Liner C2 school buses because improperly installed air conditioning electrical cables may overheat and cause a fire.
Volkswagen is recalling 2019 Jetta vehicles because the instrument cluster may fail to provide an audible warning that the key is left in the ignition.
Moore Family Farms and Creamery is recalling Cheddar Cheese Curds Cucumber Dill because they may contain elevated coliform count and generic E. coli. Consumers should discard the product.
Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.
Central Admixture Pharmacy Services is recalling 1,996 bags of oxyTOCIN in Lactated Ringer's IV bags because the company cannot assure the products are sterile. The firm lacks validation data for its sanitization procedures.
Lyons Magnus LLC is recalling Lyons Grape Juice in 4 fl oz plastic cups due to signs of bloating. The recall affects 1564 cases distributed across 13 states.
Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.
Mehlenbacher's Taffy in Watermelon flavor is being recalled due to undeclared milk allergen in the product. Consumers with milk allergies should not consume this product.
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.
Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.
Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.
C & S Wholesale Grocers Inc. is recalling Asian food products sold at Stop & Shop stores in the New York Metro Region due to improper temperature storage. Products include noodles, dumplings, egg rolls, and tofu items.
Mehlenbacher's Taffy strawberry lemonade is being recalled due to an undeclared milk allergen. Consumers with milk allergies are at risk.
Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.
Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.
The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
Olympus is recalling 9,449 bronchovideoscope units nationwide due to complaints that the endoscope can become lodged in endotracheal tube connectors due to oversized diameter.
C & S Wholesale Grocers Inc. is recalling fermented vegetable products sold at Stop & Shop in the New York Metro Region due to improper temperature storage. No illnesses have been reported.
Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.
Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.
Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.
Central Admixture Pharmacy Services is recalling 136 neonatal TPN starter bags due to lack of validated sterilization cycles. The recall affects bags distributed nationwide with lot numbers 36-262160 and 36-262146.
Burning Acre is recalling Gummy Square gummies in .12oz packages due to undeclared soy lecithin, a major allergen. Consumers with soy allergies could experience allergic reactions.
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.
Mehlenbacher's Taffy peanut butter cup pieces are recalled due to undeclared milk allergen. The product may pose a risk to consumers with milk allergies.
Central Admixture Pharmacy Services is recalling 92 bags of neonatal TPN IV bags (lot 36-262161) because of inadequate validation of manufacturing sanitization processes. The affected product was distributed nationwide.
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.
Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.
Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.
Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.
Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.
Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.
Olympus is recalling 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
C & S Wholesale Grocers Inc. is recalling 29,469 cases of various beverages sold at Stop & Shop stores in the New York Metro Region due to improper temperature storage that may have compromised product safety.
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.
Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.
C & S Wholesale Grocers is recalling approximately 29,469 cases of plant-based and tofu products sold at Stop & Shop stores in the NY Metro Region due to improper temperature control during storage and distribution.
Treehouse Foods is recalling Trader Joe's Multigrain Crackers due to metal pieces found in the product. Consumers should discontinue use and contact the company.
C & S Wholesale Grocers recalled multiple brands of dressings and dips sold at Stop & Shop stores in New York, New Jersey, and Connecticut. Products were not held at appropriate temperatures and may pose a contamination risk.
C & S Wholesale Grocers Inc. is recalling cheese and dairy alternative products sold at Stop & Shop stores in the New York Metro Region because they were not held at appropriate temperatures. Consumers should discard or return affected items.
BURNING ACRE recalled Peanut Butter Mellow Mallow 7-ounce packages due to undeclared soy lecithin and coconut allergens. The affected product was distributed in Georgia and Tennessee.
Lyons Magnus LLC is recalling GFS Harvest Valley Cranberry/Grape Juice in 4 fl oz cups due to signs of bloating observed in the product. Consumers should not consume affected juice from batch codes 9213 and 1613.
Asmus Seasoning, Inc. is recalling Asmus Seasonings Asian Spice Blend because the product contains undeclared sesame. Consumers with sesame allergies should not consume this product.
Moore Family Farms Creamery is recalling Cheddar Cheese Curds Loaded Baked Potato (1 lb bags) from Iowa due to possible E. coli and coliform contamination.
Mellow Mallow marshmallows are being recalled due to undeclared soy lecithin and coconut allergens. Consumers with allergies to these ingredients should not consume the affected product.
C & S Wholesale Grocers is recalling approximately 29,469 cases of Del Monte canned fruit products sold at Stop & Shop stores in NY, NJ, and CT because they were not held at appropriate temperatures during distribution.
Moore Family Farms Creamery is recalling Cheddar Cheese Curds from Iowa due to potential E. coli and elevated coliform contamination. Consumers should not consume the product.
Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.
Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.
Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.
Central Admixture Pharmacy Services is recalling 200 neonatal TPN IV bags (lots 36-262872 and 36-262873, expiring 8/27/2023) distributed nationwide due to lack of validated sanitization procedures.
Central Admixture Pharmacy Services recalled 40 bags of Neonatal TPN starter bags due to lack of validation data for sanitization cycles. This creates a potential sterility assurance gap for an intravenous medication used for newborns.
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The recall affects 22,112 bags nationwide.
Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.
Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was distributed nationwide.
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.
Olympus Corporation recalls Tracheal Intubation Fiberscope Models LF-P and LF-V nationwide. The device can become lodged in the endotracheal tube connector due to oversized diameter.
Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.
Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.
Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.
The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.
Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.
Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.
The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.
Beckman Coulter is recalling approximately 12,850 units of IgA diagnostic reagent due to performance failures when testing lipemic blood samples, which could lead to inaccurate test results.
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.
Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.
Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.
Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.
Looking for a different month? Back to 2023.