August 2024 recalls

595 recalls were announced in August 2024.

What the numbers show

Critical: 16
Severe: 136
High: 372
Moderate: 69
Low: 2

Of the 595 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

Which agencies issued them

301–400 of 595

HighFDA (Devices)·Z-2539-2024·2024-08-14
Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection
Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.
Product
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2462-2024·2024-08-14
GE SIGNA Premier MRI system software overheating risk to implants
GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.
Product
SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2518-2024·2024-08-14
Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process
American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.
Product
American Contract Systems Gyn Laparoscopy convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2473-2024·2024-08-14
MR System Software Defect May Cause Implant Overheating During Scanning
GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.
Product
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2460-2024·2024-08-14
GE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning
GE SIGNA Pioneer MR systems with certain software versions may allow radiofrequency exposure to exceed prescribed limits in Low SAR Mode when using specific imaging sequences, potentially causing overheating of MR conditional implants.
Product
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2481-2024·2024-08-14
SIGNA UHP MRI System Software Versions May Cause Implant Overheating
GE Medical Systems is recalling SIGNA UHP MRI systems with software versions RX28.0 or MR30.1. A configuration issue can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants.
Product
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2484-2024·2024-08-14
SIGNA MAGNUS MRI Software Can Overheat Implanted Devices
GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.
Product
SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2469-2024·2024-08-14
GE SIGNA Artist MR system may overheat implants in certain sequences
GE Medical Systems is recalling SIGNA Artist MR imaging systems because they may produce radiofrequency power exceeding user-set limits when using certain imaging sequences in Low SAR Mode, potentially causing MR-conditional implants to overheat.
Product
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2492-2024·2024-08-14
Automated Medication Cabinet Software Bug May Print Wrong Bin Labels
CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.
Product
BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1674-2024·2024-08-14
Nuts.com Ground Sumac Products Recalled for Undeclared Gluten
Nuts.com is recalling Ground Sumac products due to undeclared gluten. Products were distributed online to consumers in multiple U.S. states, Canada, and the U.S. Virgin Islands.
Product
Nuts.com Ground Sumac 1 lb resealable stand-up pouches and 20 lb double lined plastic bags in a cardboard box.
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-2527-2024·2024-08-14
Medical X-ray display system support arm may lower unexpectedly
Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.
Product
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2024·2024-08-14
SIGNA MR380 MRI system software may exceed implant heating limits
GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.
Product
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2528-2024·2024-08-14
Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly
The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.
Product
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2536-2024·2024-08-14
Steris Hookup Model 2-8-540 Documentation Error Risks Improper Endoscope Disinfection
Steris Hookup Model 2-8-540 instructions were incorrectly documented, potentially preventing proper endoscope disinfection and risking patient infection.
Product
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2540-2024·2024-08-14
Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2512-2024·2024-08-14
Baxter Precision Surgical Table Recall: Loose Spring Pins Risk
Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.
Product
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2533-2024·2024-08-14
Verigene Gram Positive Blood Culture Test Recalled for Defective Cartridges
Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2531-2024·2024-08-14
Pulmonary Heart Valve Grafts Recalled Due to Invalid Test Results
Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.
Product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2498-2024·2024-08-14
Automated Dispensing Cabinet Software Error May Print Incorrect Medication Bin Labels
CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.
Product
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2463-2024·2024-08-14
GE SIGNA HDxt 3.0T MRI systems may overheat implanted devices
GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.
Product
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2503-2024·2024-08-14
BD PYXIS Automated Dispensing Cabinet Software Issue Causes Incorrect Medication Bin Labels
A software issue in BD PYXIS automated dispensing cabinets may cause incorrect medication bin labels to print during restocking, potentially leading to medication dispensing errors. CareFusion is recalling 16 units.
Product
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2497-2024·2024-08-14
BD PYXIS MEDBANK Medication Cabinet Software Issue Causes Incorrect Bin Labels
CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.
Product
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2529-2024·2024-08-14
Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk
The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.
Product
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2537-2024·2024-08-14
Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection
Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.
Product
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1721-2024·2024-08-14
Panaderia Guatemex Champurradas Recalled for Undeclared Soy
Panaderia Guatemex is recalling Champurradas due to the presence of undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
Product
Panaderia Guatemex - Champurradas packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2530-2024·2024-08-14
Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing
Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.
Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2538-2024·2024-08-14
Steris Endoscope Reprocessor Hookups: Incorrect Instructions Risk Improper Disinfection
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
Product
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2500-2024·2024-08-14
BD PYXIS MEDBANK Software Issue Causes Incorrect Medication Bin Labels
A software issue in BD PYXIS MEDBANK automated dispensing cabinets can cause incorrect medication bin labels to print during restocking. This could lead to medication dispensing errors in healthcare facilities.
Product
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2501-2024·2024-08-14
Medication Dispensing Cabinet Software Error Can Print Incorrect Bin Labels
A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.
Product
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2024·2024-08-14
American Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
Product
American Contract Systems Cataract Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2476-2024·2024-08-14
GE SIGNA MR360 MRI System Software Defect May Overheat Implants
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
Product
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2542-2024·2024-08-14
Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2510-2024·2024-08-14
Philips IntelliVue Patient Monitors lack critical software monitoring options
Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.
Product
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2482-2024·2024-08-14
MRI System Software Error Can Cause Implant Overheating in Low SAR Mode
GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.
Product
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2478-2024·2024-08-14
GE Optima MR360 MRI System Software May Overheat Implants
GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.
Product
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1715-2024·2024-08-14
Panaderia Guatemex Conchas Guatemala pastry products recalled for undeclared soy allergen
Panaderia Guatemex is recalling Conchas Guatemala pastry products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
Product
Panaderia Guatemex - Conchas Guatemala packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2464-2024·2024-08-14
GE Discovery MR750 MRI System Software May Cause Implant Overheating
GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.
Product
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1644-2024·2024-08-14
Aldi Mixed Sourdough Loaf Recalled for Potential Plastic Contamination
Izzio Artisan Bakery is recalling 9500 cases of Aldi Mixed Sourdough loaves due to potential plastic contamination. The affected products were distributed across seven states: Illinois, Michigan, Texas, Ohio, New Jersey, Florida, and Arizona.
Product
Aldi Mixed Sourdough loaf. A single 24oz loaf packaged into plastic bag, 12 loaves per case.
Category
Food
Distribution
7 states
HighFDA (Drugs)·D-0630-2024·2024-08-14
Estradiol Cypionate Injection Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.
Product
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2024·2024-08-14
Medication dispensing cabinet software issue causes incorrect medication bin labels
A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.
Product
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2024·2024-08-14
Medline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
Product
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2470-2024·2024-08-14
GE SIGNA Voyager MRI systems risk implant overheating under specific configurations
GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.
Product
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2507-2024·2024-08-14
Integra Recalls TruDi NAV Suction Instruments for Calibration Error
Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.
Product
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2466-2024·2024-08-14
SIGNA PET/MR diagnostic imaging system poses implant overheating risk
GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.
Product
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2525-2024·2024-08-14
Siemens x-ray display system support arm may lower unexpectedly
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
Product
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1643-2024·2024-08-14
Izzio Everything Rolls recalled for potential plastic contamination
Izzio Artisan Bakery is recalling Izzio Everything Rolls due to potential plastic contamination. Affected lot numbers are 24183C and 24183A.
Product
Izzio Everything Roll packaged in 12oz plastic bag, 6 rolls per bag - 16 bags per case.
Category
Food
Distribution
7 states
HighFDA (Food)·F-1650-2024·2024-08-14
Premo Turkey & Swiss 6oz Deli Meat Recalled for Potential Salmonella
Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.
Product
Premo Turkey & Swiss 6oz, clear plastic, UPC 612510001042, 4 retail packages per wholesale case
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-2490-2024·2024-08-14
BD PYXIS automated medication cabinet software defect causes incorrect bin labels
A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.
Product
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2471-2024·2024-08-14
GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
Product
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2502-2024·2024-08-14
Automated Dispensing Cabinet Software Issue Causing Incorrect Medication Bin Labels
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
Product
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2515-2024·2024-08-14
Centurion Procedure Kits with Defective Syringes Recalled Worldwide
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.
Product
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1640-2024·2024-08-14
Lunds & Byerlys Caesar Salad Recalled for Undeclared Shellfish and Allergens
Lunds & Byerlys is recalling Grilled Chicken Caesar Salad that is mislabeled; it is actually Korean Shrimp Salad containing undeclared shellfish, tree nuts (cashew), soybeans, and sesame. Distributed in Minnesota, Lot 301335, Use By 12/04/23.
Product
Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424
Category
Food
Distribution
1 state
HighFDA (Food)·F-1649-2024·2024-08-14
Premo Meat Lovers Recall Due to Potential Salmonella Contamination
Premo Meat Lovers 7oz packages are being recalled due to potential Salmonella contamination. Affected products have a Best By Date of 7/13/24 and Lot Code 25202406.
Product
Premo Meat Lovers 7oz, clear plastic, UPC 612510093832, 4 retail packages per wholesale case
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-2472-2024·2024-08-14
GE SIGNA Creator MRI systems software defect risks patient implant overheating
GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.
Product
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2468-2024·2024-08-14
GE MR450w 1.5T MRI software defect may cause implant overheating
GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.
Product
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2461-2024·2024-08-14
MRI System Software Miscalculation May Overheat Patient Implants
A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.
Product
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1641-2024·2024-08-14
Black Forge Kitchen Knives Recalled for Elevated Lead Levels
Black Forge Knives is recalling multiple kitchen knife models distributed in Georgia and via Bespoke Post due to elevated lead levels in the blades.
Product
1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of…
Category
Consumer Product
Distribution
1 state
HighNHTSA·24V609000·2024-08-14
2023 CFMOTO Ibex 800 Motorcycles: Throttle Wire Failure Risk
CFMOTO is recalling certain 2023 Ibex 800 S and Ibex 800 T motorcycles because the throttle wire may break, causing loss of throttle control and engine stall, which increases crash risk.
Product
CFMOTO — CFMOTO IBEX800-S, IBEX800-T
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2467-2024·2024-08-14
Discovery MR450 MRI System Can Overheat Implants Under Specific Conditions
GE Discovery MR450 MRI systems with certain software versions can cause implant overheating under specific scanning conditions. 23 units worldwide require firmware updates.
Product
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1713-2024·2024-08-14
Panaderia Guatemex Sheca Redonda Bread Recalled for Undeclared Soy Allergen
Panaderia Guatemex is recalling Sheca Redonda bread due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
Product
Panaderia Guatemex - Sheca Redonda packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Food)·F-1717-2024·2024-08-14
Panaderia Guatemex Bread Recalled for Undeclared Soy Allergen
Panaderia Guatemex Liso bread may contain undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
Product
Panaderia Guatemex - Liso packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2487-2024·2024-08-14
BD PYXIS medication cabinet software error causes incorrect bin labels
A software issue in the BD PYXIS MDBNK medication dispensing cabinet may cause restock labels to print with incorrect bin locations, potentially affecting medication storage accuracy.
Product
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1724-2024·2024-08-14
Panaderia Guatemex Gusano Bread Recalled for Undeclared Soy Allergen
Panaderia Guatemex is recalling Gusano bread because it contains undeclared soy. People with soy allergies should not consume this product and should return it to the store.
Product
Panaderia Guatemex - Gusano packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Food)·F-1723-2024·2024-08-14
Panaderia Guatemex Curenitos Recalled for Undeclared Soy Allergen
Panaderia Guatemex is recalling 170 bags of Curenitos due to undeclared soy allergen. Consumers with soy allergies should not consume this product.
Product
Panaderia Guatemex - Curenitos packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2480-2024·2024-08-14
MRI System Software Issue Can Overheat Implanted Medical Devices
GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.
Product
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2532-2024·2024-08-14
FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
Product
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2465-2024·2024-08-14
GE Discovery MR750w MRI System Software May Overheat Implants
GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.
Product
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2488-2024·2024-08-14
BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units
CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.
Product
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1657-2024·2024-08-14
Palmer Patriotic Snack Mix Recalled for Potential Salmonella Contamination
Palmer & Company is recalling Palmer Patriotic Snack Mix (13 oz, Best By 1/19/25–2/1/25) due to potential Salmonella contamination. The product was distributed nationwide in the United States and Canada.
Product
Palmer Patriotic Snack Mix, A Seasonal Mix of Sweet & Salty Favorites, Net Wt. 13 oz., UPC 77232 37061, 12/13oz case
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1642-2024·2024-08-14
Izzio Everything Sourdough Recalled for Potential Plastic Contamination
Izzio Artisan Bakery is recalling Izzio Everything Sourdough bread due to potential plastic foreign material. The 24oz loaves with specific lot numbers were distributed to retailers and distribution centers in seven states.
Product
Izzio Everything Sourdough. Single 24oz loaf packaged into plastic bag. 12 loaves per case.
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-2513-2024·2024-08-14
Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating
W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.
Product
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1726-2024·2024-08-14
Panaderia Guatemex Casco bread recalled for undeclared soy allergen
Panaderia Guatemex is recalling Casco bread due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
Product
Panaderia Guatemex - Casco packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2495-2024·2024-08-14
BD PYXIS Medication Cabinet Software Defect Causes Incorrect Restock Labels
A software issue in BD PYXIS automated medication dispensing cabinets can cause restock labels to print with incorrect bin numbers. Four units are affected nationwide.
Product
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2494-2024·2024-08-14
Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels
BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.
Product
BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2459-2024·2024-08-14
SIGNA Architect MRI System Software Can Exceed Implant Heating Limits
GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.
Product
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2521-2024·2024-08-14
Surgical Convenience Kits Recalled for Potential Sterilization Failure
American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.
Product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2024·2024-08-14
Automated medication cabinet software prints incorrect bin labels
The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.
Product
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2477-2024·2024-08-14
GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk
GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.
Product
Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2520-2024·2024-08-14
Medical Procedure Kit Recalled Over Potential Sterilization Compromise
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
Product
American Contract Systems Special Procedure Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2486-2024·2024-08-14
Automated dispensing cabinet software issue causes incorrect medication bin labels
CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.
Product
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2517-2024·2024-08-14
American Contract Systems Hand Pack Convenience Kit Sterilization Failure
American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.
Product
American Contract Systems Hand Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1714-2024·2024-08-14
Panaderia Guatemex Cortado Rojo bread recalled for undeclared soy allergen
Panaderia Guatemex is recalling Cortado Rojo bread due to undeclared soy allergen. Consumers with soy allergies should not consume the product.
Product
Panaderia Guatemex - Cortado Rojo packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2541-2024·2024-08-14
Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2524-2024·2024-08-14
American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration
American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
Product
American Contract Systems Spine Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2519-2024·2024-08-14
American Contract Systems surgical kits recalled for sterilization defect
American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.
Product
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2499-2024·2024-08-14
Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels
BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.
Product
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2526-2024·2024-08-14
Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower
Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.
Product
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1720-2024·2024-08-14
Panaderia Guatemex Churros Recalled Due to Undeclared Soy Allergen
Panaderia Guatemex is recalling churros with undeclared soy allergen distributed in GA, KY, and TN. Consumers with soy allergies should not consume this product.
Product
Panaderia Guatemex - Churros packaged in plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2511-2024·2024-08-14
Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities
Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.
Product
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2024·2024-08-14
Biopsy Drape Pack sterilization failure recall from American Contract Systems
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.
Product
American Contract Systems Biopsy Drape Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1619-2024·2024-08-14
Urban River Spirits Grapefruit Mixer Recalled for Potential Under-Processing
Urban River Spirits is recalling Ruby-Red Grapefruit Mixer due to potential under-processing of the non-alcoholic beverage made in an unlicensed facility. No illnesses have been reported.
Product
Ruby-Red Grapefruit Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-1626-2024·2024-08-14
Non-alcoholic cocktail mixer recalled for potential under-processing
Urban River Spirits is recalling Lush Lavender & Wildberry Spritz non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.
Product
Lush Lavender & Wildberry Spritz is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-1634-2024·2024-08-14
Urban River Spirits Cocktail Mixer Recalled for Potential Under-Processing
Urban River Spirits Crisp Cucumber and Mint cocktail mixer recalled due to production in an unlicensed, uninspected facility. Potential under-processing poses a safety risk.
Product
Crisp Cucumber and Mint is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-1617-2024·2024-08-14
Non-Alcoholic Beverage Mixer Recalled for Potential Under-Processing Concerns
Urban River Spirits is recalling Watermelon Lemonade Splash non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed, uninspected facility, raising food safety concerns.
Product
Watermelon Lemonade Splash is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-1635-2024·2024-08-14
Cinnamon Infused Syrup Recalled from Unlicensed Manufacturing Facility
Urban River Spirits is recalling 3,876 bottles of Cinnamon Infused Simple Syrup due to manufacturing in an unlicensed, uninspected facility with potential under-processing concerns.
Product
Cinnamon Infused Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-2505-2024·2024-08-14
Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties
Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.
Product
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1615-2024·2024-08-14
Urban River Spirits Raspberry Lemon Mixer recalled for potential under-processing
Urban River Spirits is recalling Raspberry Lemon Mixer because the product was manufactured in an unlicensed and uninspected facility. The recall concerns potential under-processing issues.
Product
Raspberry Lemon Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Drugs)·D-0627-2024·2024-08-14
Acetaminophen 500mg Rapid Release Gelcaps Recalled for Carton Label Mix-up
Walgreen Co. is recalling Acetaminophen 500mg Rapid Release Gelcaps (Lot #31670346AA, expires 12/31/2026) due to incorrect carton labeling. The 21,192 affected bottles were distributed to retailers in Illinois.
Product
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1628-2024·2024-08-14
Non-Alcoholic Cocktail Mixer Recalled Due to Potential Under-Processing in Unlicensed Facility
Urban River Spirits' Spicy Orange and Mango Fusion non-alcoholic cocktail mixer is recalled due to production in an unlicensed, uninspected facility with potential under-processing. Approximately 3,876 bottles were distributed across 11 states.
Product
Spicy Orange and Mango Fusion is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-1638-2024·2024-08-14
Brown Sugar Simple Syrup Recalled for Potential Under-Processing
Urban River Spirits is recalling Brown Sugar Simple Syrup due to manufacture in an unlicensed, uninspected facility with potential under-processing concerns.
Product
Brown Sugar Simple Syrup is a non-alcoholic cocktail mixer. Product is packaged in glass 5oz. bottle and sold under brand Urban River Spirits.
Category
Food
Distribution
11 states

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