The Recall Desk

Archive

November 2023 recalls

649 recalls were announced in November 2023.

What the numbers show

Critical
20
Severe
190
High
373
Moderate
63
Low
3

Of the 649 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

301–400 of 649

  • SevereFDA (Food)·F-0356-2024·2023-11-15

    Diced Yellow Onions from Gills Onions Recalled for Salmonella Contamination

    Gills Onions is recalling fresh diced yellow onions due to potential contamination with Salmonella Thompson. Affected products were distributed to multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Devices)·Z-0185-2024·2023-11-15

    BD Alaris Syringe Module includes non-validated compatible syringes in labeling

    CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.

    Product
    BD Alaris Syringe Module, REF 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0334-2024·2023-11-15

    Fresh Red Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions, LLC is recalling Cross Valley Farms fresh diced red onions due to potential Salmonella Thompson contamination. The recalled product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Cross Valley Farms 1/5LB CTN FRESH 1/4" DICED RED ONIONS W/ZIP
    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-0357-2024·2023-11-15

    Gills Onions Fresh Diced Yellow Onions Recalled for Salmonella Thompson

    Gills Onions is recalling fresh diced yellow onions due to potential contamination with Salmonella Thompson. The recalled product was distributed to multiple US states and Canadian provinces.

    Product
    Gills Onions 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (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
  • 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-0320-2024·2023-11-15

    Dietary supplement seltzer recalled for undeclared allergens and unapproved additive

    Kula Brands is recalling Piña Colada + Kratom Seltzer because it contains undeclared milk and coconut allergens and unapproved kratom. Affected consumers should not consume the product.

    Product
    Kula Can Pin¿a Colada + KRATOM SELTZER, 12 oz (355ML) DIETARY SUPPLEMENT
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0344-2024·2023-11-15

    Cross Valley Farms Slivered Yellow Onions Recalled for Salmonella Contamination Risk

    Gills Onions, LLC recalls Cross Valley Farms fresh slivered yellow onions for potential Salmonella Thompson contamination. The 1,800 lb recall affects 37 U.S. states and 5 Canadian provinces.

    Product
    Cross Valley Farms 4/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
    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 (Drugs)·D-0101-2024·2023-11-15

    Lidocaine injection recalled due to glass particulate matter

    Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% injection due to presence of glass particulate matter. Lot 42290DK with expiration 6/1/2024 is affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0365-2024·2023-11-15

    Imperial Fresh Diced Red Onions Recalled for Potential Salmonella Contamination

    Gills Onions, LLC is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The affected product was distributed across the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED RED ONIONS W/ZIPPER SYSCO 3295219
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0102-2024·2023-11-15

    Pfizer Lidocaine Injection Recall: Glass Particulates in Injectable Medication

    Pfizer is recalling 3,200 vials of Lidocaine Hydrochloride 2% Injection due to the presence of glass particulates. The injectable medication was distributed nationwide in the US and Puerto Rico.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-0400-2024·2023-11-15

    Gills Onions sliced yellow onions recalled due to Salmonella contamination

    Gills Onions is recalling Ready Set Serve sliced onions due to potential Salmonella Thompson contamination. Affected consumers should not consume the product.

    Product
    Ready Set Serve 2/5 LB CTN FRESH 3/16" W/SLICE "G" CUT YLW W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0362-2024·2023-11-15

    Gills Onions Slivered Yellow Onions Recalled for Salmonella Contamination

    Gills Onions is recalling 1,100 pounds of fresh 1/8" slivered yellow onions due to potential contamination with Salmonella Thompson. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 2/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
    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-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-0331-2024·2023-11-15

    Gills Onions 8 oz cups recalled for potential Salmonella Thompson contamination

    Gills Onions is recalling 8 oz cups of diced celery and onions due to potential Salmonella Thompson contamination. Consumers should not consume affected products and should discard or return them.

    Product
    Gills Onions 8 oz cups, diced celery & onions
    Category
    Food
    Distribution
    36 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-0335-2024·2023-11-15

    Cross Valley Farms diced red onion recalled due to Salmonella Thompson risk

    Gills Onions, LLC is recalling Cross Valley Farms 2/5 LB diced red onion product due to potential Salmonella Thompson contamination. The product was distributed to Canada and numerous U.S. states.

    Product
    Cross Valley Farms 2/5 LB CTN FRESH 1/4" DICED RED ONION W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0352-2024·2023-11-15

    Gills Onions red onion slivers recalled for potential Salmonella contamination

    Gills Onions has recalled fresh slivered red onions (product 5514182006) due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Gills Onions 4/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 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-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-0369-2024·2023-11-15

    Gills Onions Recalls Red Onions for Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh slivered red onions (760 lb) due to potential Salmonella Thompson contamination. Affected lot codes were distributed to 38 US states and five Canadian provinces.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0378-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions, LLC 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 2/5 LB CTN FRSH 3/8" DICED YLW ONION W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0373-2024·2023-11-15

    Gills Onions diced yellow onions recalled for Salmonella contamination

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

    Product
    Imperial Fresh 4/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 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-0319-2024·2023-11-15

    Enoki mushrooms recalled due to possible Listeria monocytogenes contamination

    Qilu Enterprises brand enoki mushrooms (7.05 oz packages, UPC 928918-610109) are being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed in NY, NJ, MA, CT, PA, and MD.

    Product
    Qilu Enterprises brand enoki mushrooms packaged in a 7.05 ounce (200 gram) flexible plastic bag with UPC code 928918-610109.
    Category
    Food
    Distribution
    6 states
  • 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 (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-0397-2024·2023-11-15

    Diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions, LLC is recalling Ready Set Serve diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Ready Set Serve 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0368-2024·2023-11-15

    Red Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling Imperial Fresh sliced red onions due to potential Salmonella Thompson contamination. The affected lots have been distributed across multiple U.S. states and Canadian provinces.

    Product
    Imperial Fresh 1/5 LB CTN FRSH 1/4" SLVRD RED ONIONS W/ZIPPER
    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-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 (Devices)·Z-0189-2024·2023-11-15

    Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk

    Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0394-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Contamination

    Gills Onions, LLC is recalling Ready Set Serve diced yellow onions due to potential Salmonella Thompson contamination. Affected products were distributed to retailers and food services across the United States and Canada.

    Product
    Ready Set Serve 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0367-2024·2023-11-15

    Diced Red Onions Recalled for Potential Salmonella Contamination

    Imperial Fresh diced red onions distributed across the US and Canada are being recalled due to potential Salmonella Thompson contamination. The affected product was distributed to multiple states and provinces.

    Product
    Imperial Fresh 2/5 LB CTN FRSH 3/8" DICED RED ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • 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-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-0379-2024·2023-11-15

    Imperial Fresh Diced Onions Recalled for Potential Salmonella Contamination

    Imperial Fresh diced yellow onions from Gills Onions, LLC are being recalled due to potential Salmonella Thompson contamination. The recall affects 88,660 lb distributed across the US and Canada.

    Product
    Imperial Fresh4/5 LB CTN FRSH 3/8" 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-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…
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Food)·F-0372-2024·2023-11-15

    Diced Yellow Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions, LLC is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The 1,940-pound recall affects products distributed in the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0383-2024·2023-11-15

    Gills Onions Slivered Yellow 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 31 U.S. states and five Canadian provinces.

    Product
    Imperial Fresh 4/5LB CTN FRESH 1/8" SLIVERED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • 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 (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-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 (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-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-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 (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-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-0261-2024·2023-11-15

    Pregnancy Test Kits Recalled Due to Improper Storage Conditions

    Family Dollar Stores is recalling 329,044 CLEARBLUE pregnancy test kits that were stored outside labeled temperature requirements from June to October 2023 at stores in 22 states.

    Product
    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
    Category
    Medical Device
    Distribution
    23 states
  • 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 (Devices)·Z-0289-2024·2023-11-15

    DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly

    Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.

    Product
    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of…
    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-0278-2024·2023-11-15

    Philips DigitalDiagnost C90 radiography system ceiling-mount failure risk

    Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.

    Product
    DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-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-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-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-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
  • HighFDA (Devices)·Z-0219-2024·2023-11-15

    Blood Lead Test Kits Recalled for Defective Treatment Reagent Caps

    Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.

    Product
    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0271-2024·2023-11-15

    Philips CombiDiagnost R90 radiography systems recalled for ceiling mount failure

    Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.

    Product
    CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
    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-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 (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-0222-2024·2023-11-15

    Patient Alarm Pendant with Wristband Recalled for Premature Battery Depletion

    Securitas Healthcare is recalling its Arial Water Resistant Pendant (Models 59362 and 2560-59362) due to premature battery depletion, which may prevent alarms from being received by the emergency call system.

    Product
    Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
    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 (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 (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 (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-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-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-0221-2024·2023-11-15

    Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

    Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

    Product
    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
    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-0240-2024·2023-11-15

    Stryker Surgical Forceps Recalled for Incorrect Expiration Date Label

    Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
    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-0243-2024·2023-11-15

    Stryker disposable surgical forceps recalled for incorrect expiration date labeling

    Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2024·2023-11-15

    Disposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label

    Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2024·2023-11-15

    Surgical Procedure Pack Contains Latex Despite 'Latex-Free' Label

    Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.

    Product
    Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0274-2024·2023-11-15

    DigitalDiagnost 4 Radiographic Systems Risk of Ceiling Mount Failure

    DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.

    Product
    DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2024·2023-11-15

    Stryker Disposable Spetzler-Malis Bipolar Forceps Expiration Date Mislabeled

    Stryker Corporation recalled disposable surgical forceps with mislabeled expiration dates. The product label incorrectly indicates a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0258-2024·2023-11-15

    DJO EMPOWR Knee Punch Handle Tip May Break During Surgery

    Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.

    Product
    DJO EMPOWR Knee Punch Handle, REF: 801-05-040
    Category
    Medical Device
    Distribution
    24 states

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