The Recall Desk

Archive

November 2023 recalls

649 recalls were announced in November 2023.

What the numbers show

Critical
20
Severe
181
High
382
Moderate
63
Low
3

Of the 649 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

301–400 of 649

  • SevereFDA (Devices)·Z-0193-2024·2023-11-15

    Olympus Bronchovideoscope Recalled Due to Combustion Risk

    Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.

    Product
    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0151-2024·2023-11-15

    Novum IQ Syringe Pump may falsely indicate infusion completion

    Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.

    Product
    Novum IQ Syringe infusion system, Product Code 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0286-2024·2023-11-15

    Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile

    Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.

    Product
    Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0323-2024·2023-11-15

    HEB Kale Greens recalled for possible Listeria monocytogenes contamination

    Safeway Fresh Foods LLC is recalling 528 cases of HEB Kale Greens (16 oz.) due to possible Listeria monocytogenes contamination. Affected product distributed in Texas with expiration dates 10/11/23 and 10/12/23.

    Product
    HEB Kale Greens, Net Wt. 16 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0396-2024·2023-11-15

    Diced Onions Recalled Due to Potential Salmonella Thompson Contamination

    Gills Onions is recalling diced yellow onions sold under the Ready Set Serve brand due to potential Salmonella Thompson contamination. The affected product was distributed in the United States and Canada.

    Product
    Ready Set Serve 2/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0353-2024·2023-11-15

    Gills Onions Fresh Diced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling 1/5 pound containers of fresh diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 1/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0420-2024·2023-11-15

    Mini Fruit Jelly Cups Recalled for Choking Hazard

    Tiffany Food Corp. is recalling Mini Fruit Jelly Cups due to choking hazard. The product was distributed in New York, New Jersey, and Pennsylvania.

    Product
    Mini Fruit Jelly Cups; Assorted Flavor; UPC: 4 714379 320985, Net Wt. 52.9 oz
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0350-2024·2023-11-15

    Gills Onions Fresh Diced Red Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling 1,600 pounds of Fresh Diced Red Onions due to potential contamination with Salmonella Thompson. The affected product was distributed to multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 4/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereNHTSA·23V769000·2023-11-15

    Volvo VN and VHD trucks recalled for inadequate bench seat attachment

    Volvo is recalling 2019-2024 VN and VHD trucks because passenger side bench seats may be inadequately attached to the floor. If the seat attachment fails during a crash, the seat could shift, increasing the risk of injury.

    Product
    VOLVO — VOLVO VHD, VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0422-2024·2023-11-15

    Mini Fruit Jelly Cups Recalled for Choking Hazard

    Tiffany Food Corp. is recalling Mini Fruit Jelly Cups (Mango flavor) distributed in NY, NJ, and PA due to choking hazard.

    Product
    Mini Fruit Jelly Cups; Mango flavor; UPC: 4 714379 321005, Net Wt. 52.9 oz
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0395-2024·2023-11-15

    Ready Set Serve Diced Yellow Onions Recalled for Salmonella Thompson

    Gills Onions is recalling Ready Set Serve diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across Canada and the United States.

    Product
    Ready Set Serve 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0385-2024·2023-11-15

    Sliced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. Affected products were distributed across multiple U.S. states and Canadian provinces.

    Product
    Imperial Fresh 4/5LB CTN FRESH 3/16" SLIVERED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0341-2024·2023-11-15

    Fresh Diced Yellow Onions Recalled Due to Salmonella Contamination

    Gills Onions, LLC is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the United States and Canada.

    Product
    Cross Valley Farms 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0404-2024·2023-11-15

    Schnucks Apple Sauce Fruit Pouches Recalled for High Lead Content

    Schnucks apple sauce fruit pouches with cinnamon are being recalled because North Carolina health officials found high levels of lead in the product. Consumers should not consume the affected pouches.

    Product
    Schnucks APPLE SAUCE FRUIT POUCH, CINNAMON Net Weight: 3.2 oz (90g) Pouches, 20 pack-3.2 oz poches per carton, 12 pack-3.2 oz poches per carton, 20 pack-3.2 oz poches per carton, 4 pack-3.2 oz poches per carton
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0342-2024·2023-11-15

    Fresh Diced Yellow Onions Recalled for Salmonella Thompson Contamination

    Cross Valley Farms Fresh Diced Yellow Onions are recalled due to potential Salmonella Thompson contamination. The product was distributed in the United States and Canada.

    Product
    Cross Valley Farms 2/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0332-2024·2023-11-15

    Gills Onions Diced Mirepoix Recalled for Salmonella Thompson Contamination

    Gills Onions is recalling 10 oz cups of diced mirepoix due to potential Salmonella Thompson contamination. Affected products were distributed across Canada and the United States.

    Product
    Gills Onions 10 oz cups, diced mirepoix
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0329-2024·2023-11-15

    Gills Onions diced yellow onions recalled for potential Salmonella contamination

    Gills Onions is recalling 3 lb. bags of diced yellow onions potentially contaminated with Salmonella Thompson. Affected products have specific lot numbers and use-by dates through August 28, 2023.

    Product
    Gills Onions 3 lb. bags, diced yellow onions
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0382-2024·2023-11-15

    Slivered Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects onions distributed across the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/8" SLIVERED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0330-2024·2023-11-15

    Gills Onions diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions 8 oz cups of diced yellow onions are being recalled due to potential contamination with Salmonella Thompson. Consumers should not consume affected products and should discard them or return them to the place of purchase.

    Product
    Gills Onions 8 oz cups, diced yellow onions
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0377-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh diced yellow onions (2,035 lb) due to potential contamination with Salmonella Thompson. The affected product was distributed to multiple US states and Canadian provinces.

    Product
    Imperial Fresh 1/5 LB CTN FRSH 3/8" DICED YLW ONIONS W/ ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0374-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Imperial Fresh 1/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0403-2024·2023-11-15

    Weis Cinnamon Apple Sauce Recalled for High Lead Contamination

    Weis brand cinnamon apple sauce pouches are recalled due to high levels of lead contamination detected by the North Carolina Department of Health and Human Services. Consumers should stop consuming the product and contact their healthcare provider if concerned.

    Product
    Weis CINNAMON APPLE SAUCE, Net Weight: 3.2 oz (90g) Pouches, 20 pack-3.2 oz poches per carton, NET WT 4LB carton, 12 pack 3.2 oz poches per carton, 4 pack 3.2 oz poches per carton.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0351-2024·2023-11-15

    Gills Onions Red Onions Recalled for Potential Salmonella Contamination

    Gills Onions has recalled slivered red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 2/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0370-2024·2023-11-15

    Slivered Red Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions, LLC is recalling Imperial Fresh slivered red onions due to potential contamination with Salmonella Thompson. The recalled products were distributed across the United States and Canada.

    Product
    Imperial Fresh 4/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0384-2024·2023-11-15

    Imperial Fresh Slivered Onions Recalled for Salmonella Contamination

    Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Imperial Fresh 2/5LB CTN FRESH 3/16" SLIVERED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0401-2024·2023-11-15

    Gills Onions sliced onions recalled for potential Salmonella contamination

    Gills Onions is recalling 5,960 lb of Ready Set Serve sliced onions due to potential Salmonella Thompson contamination. The affected product was distributed across Canada and 36 U.S. states.

    Product
    Ready Set Serve 2/5LB CTN FRESH 3/16" STRIP SLIVERED "G" W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0387-2024·2023-11-15

    Fresh Red Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling PEAK brand fresh diced red onions due to potential Salmonella Thompson contamination. The recall affects products distributed across 35 US states and five Canadian provinces.

    Product
    PEAK 4/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0322-2024·2023-11-15

    HEB Kale Greens Recalled Due to Possible Listeria Contamination

    HEB Kale Greens in Texas are being recalled due to possible Listeria monocytogenes contamination. Consumers should discard the affected product or return it to the store.

    Product
    HEB Kale Greens, Net Wt. 32oz
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0366-2024·2023-11-15

    Diced Red Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed to foodservice and retail distributors in the United States and Canada.

    Product
    Imperial Fresh 4/5 LB CTN FRESH 1/4" DICED RED W/ZIPPER SYSCO 4705317
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0421-2024·2023-11-15

    Mini Fruit Jelly Cups with Lychee Recalled for Choking Hazard

    Tiffany Food Corp. is recalling Mini Fruit Jelly Cups with lychee flavor because they pose a choking hazard. The recall covers 120 cases distributed in New York, New Jersey, and Pennsylvania.

    Product
    Mini Fruit Jelly Cups; Lychee; UPC: 4 714379 320992, Net Wt. 52.9 oz
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0364-2024·2023-11-15

    Diced Red Onions Recalled Due to Salmonella Contamination Risk

    Gills Onions is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple US states and Canadian provinces.

    Product
    Imperial Fresh 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER SYSCO
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0402-2024·2023-11-15

    WANABANA apple cinnamon fruit puree recalled for high lead levels

    WANABANA apple cinnamon fruit puree pouches are recalled due to high levels of lead detected by the North Carolina Department of Health and Human Services. Approximately 2.99 million units are affected across multiple regions.

    Product
    WANABANA APPLE CINNAMON FRUIT PUREE, Net Weight: 2.50 oz (71g) Pouches, 15 poches per carton, 3-pack carton in one box.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0347-2024·2023-11-15

    Fresh Red Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling 325 lb of fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0388-2024·2023-11-15

    Fresh diced yellow onions recalled by Gills Onions for Salmonella contamination

    Gills Onions, LLC is recalling fresh 1/2-inch diced yellow onions due to potential Salmonella Thompson contamination. The product should be discarded or returned to the point of purchase.

    Product
    PEAK 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0100-2024·2023-11-15

    Sodium Bicarbonate Injection recalled due to glass contamination

    Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection (24,900 vials) nationwide due to the presence of glass particulate matter. This Class I recall affects an injectable medication used in healthcare settings.

    Product
    4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0192-2024·2023-11-15

    Olympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk

    Olympus is recalling bronchovideoscopes nationwide due to a risk of combustion inside the bronchial passages during high-frequency cauterization if oxygen is supplied or the electrode is positioned too close to the scope's tip.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0190-2024·2023-11-15

    Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery

    Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0184-2024·2023-11-15

    Alaris PCA Module 8120 infusion pump recalled for unvalidated syringes

    CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.

    Product
    BD Alaris PCU REF 8015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2024·2023-11-15

    Disposable Spetzler-Malis Bipolar Forceps recalled for expiration date labeling discrepancy

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar Forceps because the product label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2024·2023-11-15

    Stryker Portal Entry Kit Recalled Due to Expired Product Distribution

    Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.

    Product
    Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0280-2024·2023-11-15

    ProxiDiagnost N90 X-ray Systems Recalled for Potential Ceiling Mount Failure

    Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.

    Product
    ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2024·2023-11-15

    DigitalDiagnost C90 radiographic system poses ceiling-mount failure risk

    Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.

    Product
    DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2024·2023-11-15

    Philips DigitalDiagnost C90 Radiographic Systems Recalled for Ceiling Mount Failure

    Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.

    Product
    DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2024·2023-11-15

    Philips radiographic imaging system ceiling units risk of falling

    Philips EasyDiagnost Eleva DRF digital radiographic systems mounted on ceilings may fail and fall. 40 units nationwide are being recalled due to potential ceiling mount failure.

    Product
    EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0346-2024·2023-11-15

    Cross Valley Farms Slivered Onions Recalled for Potential Salmonella Contamination

    Gills Onions, LLC is recalling Cross Valley Farms slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects 6,400 pounds distributed across the United States and Canada.

    Product
    Cross Valley Farms 4/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0130-2024·2023-11-15

    B. Braun AMO Administration Set Recalled for Manufacturing Defect Causing Leakage

    B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.

    Product
    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2024·2023-11-15

    Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recall for Incorrect Expiration Date Labeling

    Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2024·2023-11-15

    Arial Water Resistant Pendant Alarm Recalled for Battery Depletion Risk

    Securitas Healthcare is recalling Arial Water Resistant Pendants (models 59360 and 2560-59360) due to premature battery depletion that may prevent emergency alarms from being received.

    Product
    Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2024·2023-11-15

    Philips Affiniti 70 Ultrasound System Software Defect May Cause Delayed Images

    Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.

    Product
    Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0249-2024·2023-11-15

    Stryker Bipolar Forceps Recalled for Incorrect Expiration-Date Labeling

    Stryker Corporation is recalling 2,321 Disposable Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. Products labeled with 54-month shelf life actually have a 36-month shelf life.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2024·2023-11-15

    Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage

    B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.

    Product
    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2024·2023-11-15

    CardioMEMS Patient Electronic System power connector damage risk

    St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.

    Product
    CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2024·2023-11-15

    Fogarty Thru-Lumen Embolectomy Catheter Recalled for Delayed Balloon Deflation

    Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.

    Product
    Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0247-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recalled for Expiration Date Labeling Error

    Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recalled for Overstated Shelf Life

    Stryker Corporation recalls 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The actual shelf life is 36 months, but labels indicate 54 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0128-2024·2023-11-15

    B. Braun FT1000S Fluid Transfer Sets may leak, risking infection

    B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose healthcare workers to hazardous medication.

    Product
    FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2024·2023-11-15

    IV Fitting Components Recalled Due to Manufacturing Defect and Leakage Risk

    B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing bloodstream infection risk.

    Product
    BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2024·2023-11-15

    Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling

    AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0290-2024·2023-11-15

    Medical device blood oxygenation system recalled due to defective weld

    Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.

    Product
    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2024·2023-11-15

    SA3000 intravenous adapters recalled for manufacturing defect causing leakage

    B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.

    Product
    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2024·2023-11-15

    DigitalDiagnost 4 Ceiling-Mounted X-Ray Units Recall for Fall Hazard

    Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.

    Product
    DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0406-2024·2023-11-15

    Nutricia KetcoCal 4:1 Recall: Incorrect Product in Packaging

    Nutricia is recalling KetcoCal 4:1 LQ Unflavored sample kits due to incorrect product in packaging. A total of 283 kits distributed to the US and Canada expire December 10, 2023.

    Product
    Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0259-2024·2023-11-15

    Monitron II Waveform Analyzer Screen Freeze Defect in Ventilator Models

    Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.

    Product
    Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0090-2024·2023-11-15

    Prescription Drug Recalled Due to Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0345-2024·2023-11-15

    Cross Valley Farms Fresh Slivered Yellow Onions Recalled for Salmonella

    Gills Onions, LLC is recalling Cross Valley Farms fresh slivered yellow onions due to potential Salmonella Thompson contamination. Distribution affected the United States and Canada.

    Product
    Cross Valley Farms 2/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0227-2024·2023-11-15

    Medical imaging systems recalled for missing safety spacer and warning label

    Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.

    Product
    Integris-Allura IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0224-2024·2023-11-15

    Philips surgical imaging systems missing warning label and safety spacer

    Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.

    Product
    BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0228-2024·2023-11-15

    X-ray imaging systems recalled for missing warning label and spacer

    Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.

    Product
    Allura Xper IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0340-2024·2023-11-15

    Fresh Diced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions is recalling Cross Valley Farms fresh diced yellow onions due to potential Salmonella Thompson contamination. Consumers should not consume the affected product.

    Product
    Cross Valley Farms 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • HighFDA (Food)·F-0318-2024·2023-11-15

    Hinterland Dairy Cheese Recalled for Potential E. Coli Contamination

    Hinterland Dairy Farmstead Cheese French Onion + Chive (8oz packages, Lot 1670) distributed in Iowa may contain E. coli. The FDA issued a Class II recall; consumers should discard the product or return it to their retailer.

    Product
    Hinterland Dairy Farmstead Cheese French Onion + Chive, a jack-style cheese, packaged in 8oz packages.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0325-2024·2023-11-15

    Edible Cookie Dough Chocolate Chip Recalled for Undeclared Peanut Butter

    Cookies-n-Milk Incorporated is recalling Edible Cookie Dough Chocolate Chip due to undeclared peanut butter. The product contains peanut butter dough mislabeled as chocolate chip, posing a risk to consumers with peanut allergies.

    Product
    Edible Cookie Dough Chocolate Chip packaged in 6 oz plastic cups lot # 3240
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0321-2024·2023-11-15

    Greenhead Lobster Products Recalls Frozen and Fresh Lobster Meat for Listeria

    Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.

    Product
    Frozen and fresh RTE Lobster meat (1 lb. packages to 12 lb. case) 1. Greenhead Lobster HPP Fresh Cooked Claw and Knuckle Meat GHL-CKF - Fresh - 1 lb. oxygen permeable bag, master cased in a 12 lbs. Styrofoam box 2. Greenhead Lobster Fresh Cooked Claw and Knuckle Meat GHL-CKF -C
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0226-2024·2023-11-15

    Surgical C-arm systems recalled for missing warning label and spacer

    Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.

    Product
    Zenition 50 & 70 Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0328-2024·2023-11-15

    Infant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive

    Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.

    Product
    Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0281-2024·2023-11-15

    RSP Humeral Socket Inserts Swapped During Packaging by Encore Medical

    Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.

    Product
    RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0407-2024·2023-11-15

    Stewarts Chocolate Chip Cookies recalled for undeclared macadamia nuts

    The Cookie Factory LLC is recalling Stewarts Chocolate Chip Cookies (6 oz packages) because they contain undeclared macadamia nuts, posing an allergen risk to consumers with macadamia nut allergies.

    Product
    Stewarts Chocolate Chip Cookies; 6 oz package; packaged in a flexible plastic clamshell type package
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0273-2024·2023-11-15

    Philips DigitalDiagnost 4 radiographic systems risk of ceiling mounting failure

    Philips DigitalDiagnost 4 Flex/Value radiographic systems may fail when ceiling-mounted and fall, posing injury risk. Recall affects 92 units distributed nationwide.

    Product
    DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2024·2023-11-15

    Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images

    Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.

    Product
    Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Drugs)·D-0086-2024·2023-11-15

    Drug Recall: Montelukast Sodium Tablets Contaminated with Foreign Metoprolol Tablet

    Dr. Reddy's Laboratories is recalling 1,656 bottles of Montelukast Sodium 10 mg tablets due to contamination with a foreign metoprolol tablet found in at least one bottle. Affected lots were distributed nationwide.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2024·2023-11-15

    Radiology software may fail to update patient records in external systems

    Change Healthcare Radiology Solutions versions 14.0, 14.1, and 14.2 may fail to update records in external applications. Healthcare facilities using this software are affected across six countries.

    Product
    Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0254-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0316-2024·2023-11-15

    Hinterland Dairy Farmstead Cheese Mango Habanero Recalled for E. coli Risk

    Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.

    Product
    Hinterland Dairy Farmstead Cheese Mango Habanero, a jack-style cheese, packaged in 8oz packages.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0277-2024·2023-11-15

    Radiographic Imaging System Recall Due to Ceiling Mount Failure Risk

    Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.

    Product
    DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2024·2023-11-15

    Allergan Universal Fill Kit for tissue expanders recalled due to leakage risk

    B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.

    Product
    ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0317-2024·2023-11-15

    Hinterland Dairy Farmstead Cheese recalled for potential E. coli contamination

    Hinterland Dairy Inc is recalling Jalapeno Happy Jack Monterey Jack cheese due to potential E. coli contamination. The affected product was distributed in Iowa.

    Product
    Hinterland Dairy Farmstead Cheese Jalapeno Happy Jack Monterey Jack, packaged in bulk and 8oz packages.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0095-2024·2023-11-15

    FDA Recalls Deferasirox Tablets for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.

    Product
    DEFERASIROX — DEFERASIROX (DEFERASIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2024·2023-11-15

    Family Dollar Pregnancy Test Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0246-2024·2023-11-15

    Stryker Bipolar Surgical Forceps Recalled for Incorrect Expiration Label

    Stryker Corporation is recalling 2,321 units of disposable bipolar surgical forceps with incorrect expiration dates on their labels. The devices are labeled with a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2024·2023-11-15

    Burette Assembly With Stopcock Recalled Due to Manufacturing Defect and Leakage Risk

    B. Braun Medical is recalling 400 units of a 30ML burette assembly due to a manufacturing defect that may cause leakage, potentially delaying therapy and increasing bloodstream infection risk.

    Product
    30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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