The Recall Desk

Archive

April 2024 recalls

478 recalls were announced in April 2024.

What the numbers show

Critical
6
Severe
89
High
326
Moderate
55
Low
2

Of the 478 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

Which agencies issued them

201–300 of 478

  • HighFDA (Devices)·Z-1516-2024·2024-04-17

    PEG feeding tube with blocked connector may impede placement procedure

    Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.

    Product
    EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1127-2024·2024-04-17

    Yellow onions recalled due to incomplete botulinum hazard analysis

    Pueblo Fruits is recalling 23 cases of yellow onions sold to a single restaurant in Albuquerque because the firm did not complete a hazard analysis for potential Clostridium botulinum growth in vacuum-sealed bags.

    Product
    Onion Yellow Med 3 Outer Rings 4-5 LB in a 5 LB ,vacuum sealed, clear plastic bag. Labeling: White paper label with the following information attached to the outside of plastic bag. Blake's (Richmond) Onion Yellow Med 3 Outer Rings 4-5 LB PO# 047981 Lot#787806-6883R5…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1482-2024·2024-04-17

    RayStation Software Use Error Could Cause Incorrect Radiation Dose Calculations

    RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.

    Product
    RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1148-2024·2024-04-17

    Deluxe brand Macarons Party Edition recalled for undeclared allergens

    Lidl is recalling Deluxe Macarons Party Edition due to undeclared allergens. The packaging is labeled in a foreign language and does not identify wheat, soy, egg, milk, and tree nuts.

    Product
    Deluxe brand Macarons Party Edition 35 pieces 455g (35 x 13g) UPC:4056489365365 Product packaged in a cardboard/plastic container
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1497-2024·2024-04-17

    Acetabular Bearing Components Recalled for Marketing Without FDA Clearance

    Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.

    Product
    ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2024·2024-04-17

    da Vinci SP Surgical System Patient Cart Welds May Fail

    Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.

    Product
    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1126-2024·2024-04-17

    SWAD Cinnamon Powder Recalled Due to Lead Contamination

    RAJA FOODS LLC is recalling SWAD BRAND CINNAMON POWDER (3.5 oz) after testing confirmed lead contamination. The affected batch should not be consumed.

    Product
    SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, 20 retail units per wholesale case
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1506-2024·2024-04-17

    Chromophare Surgical Light System recalled for insufficient mounting force

    Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.

    Product
    Chromophare Surgical Light System , REF CH00000001
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V275000·2024-04-17

    Lexus LS Air Bag Sensor May Fail to Detect Front Passenger

    Toyota is recalling certain 2018–2021 Lexus LS and LS Hybrid vehicles with the Executive Package because the front passenger seat occupant sensor may fail to detect a passenger, risking improper air bag deployment in a crash.

    Product
    LEXUS — LEXUS LS HYBRID, LS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2024·2024-04-17

    EndoVive 20Fr Push Safety PEG Kit Recall Due to Blocked Lumen Risk

    Boston Scientific is recalling the EndoVive 20Fr PEG feeding kit due to blockage in the barb connector that can prevent proper placement. The blockage may lead to prolonged procedures, bleeding, gastric leakage, and aspiration risk.

    Product
    EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2024·2024-04-17

    Medical Device Recall: Blood Pressure Monitors With Defective Power Cord Insulation

    Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.

    Product
    Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1138-2024·2024-04-17

    Hashbrown Casserole Recalled Due to Missing Ingredient Labeling

    Robeson Enterprises is recalling Pies & Sides Hashbrown Casserole because the label lacks an ingredient list, preventing consumers from identifying allergens. The product was distributed in Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES HASHBROWN CASSEROLE, ALLERGENS: MILK, WHEAT, SOY, FISH, PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1133-2024·2024-04-17

    PIES & SIDES Broccoli Casserole Recalled for Missing Ingredient Labels

    PIES & SIDES Broccoli Casserole by Robeson Enterprises is recalled because the product label does not list ingredients. The product contains wheat, eggs, milk, soy, and fish.

    Product
    PIES & SIDES Broccoli Casserole Contains: Wheat, Eggs, Milk, Soy, Fish PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1511-2024·2024-04-17

    Baxter Power Cords Recalled for Electrical Insulation Non-Compliance

    Baxter Healthcare is recalling power cord models globally because the insulation does not meet electrical safety standards, creating a potential risk of electrical shock or fire.

    Product
    Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1514-2024·2024-04-17

    PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement

    Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.

    Product
    EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1144-2024·2024-04-17

    Squash casserole recalled for missing ingredient and allergen labeling

    Robeson Enterprises is recalling its Pies & Sides squash casserole due to missing ingredient list labeling. The product contains undisclosed allergens (milk, eggs, soy, fish, wheat).

    Product
    PIES & SIDES SQUASH CASSEROLE CONTAINS: MILK, EGGS, SOY, FISH, WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1146-2024·2024-04-17

    Sweet Potato Casserole Recall Due to Missing Ingredient Labels

    Robeson Enterprises is recalling Pies & Sides Sweet Potato Casserole because the product label fails to list any ingredients, including egg and milk. Consumers with allergies to these ingredients should not consume the product.

    Product
    PIES & SIDES SWEET POTATO CASSEROLE CONTAINS: EGG, MILK PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1135-2024·2024-04-17

    Caramel Apple Pie Recalled for Missing Sub-Ingredient Labels

    Robeson Enterprises is recalling 2,984 units of Pies & Sides Connie's Caramel Apple Pie due to incomplete ingredient labeling. The product labels do not list sub-ingredients for prepared components.

    Product
    PIES & SIDES CONNIE'S CARAMEL APPLE PIE 11 oz INGREDIENTS: APPLE PIE FILLING, SUGARS, VANILLA, CARAMEL EXTRACT BLEACHED FLOUR, SPICES, CONTAINS: WHEAT, PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1145-2024·2024-04-17

    Robeson Enterprises Recalls Strawberry Pie for Missing Sub-Ingredient Labeling

    Robeson Enterprises is recalling Pies & Sides Strawberry Pie because the label fails to list sub-ingredients. Consumers with allergies cannot verify safe ingredients. The recall affects Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES STRAWBERRY PIE INGREDIENTS: STRAWBERRY PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1134-2024·2024-04-17

    Cherry Pie Recalled for Missing Sub-Ingredient Label Information

    Robeson Enterprises is recalling cherry pie products because labels do not list sub-ingredients. Products were distributed in Georgia, North Carolina, and South Carolina.

    Product
    PIES & SIDES CHERRY PIE INGREDIENTS: CHERRY PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR SPICES. CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0438-2024·2024-04-17

    FDA Recalls Lansoprazole Delayed-Release Capsules for Manufacturing Practice Deviations

    NATCO Pharma Limited is voluntarily recalling 30 bottles of Lansoprazole 15 mg delayed-release capsules due to Current Good Manufacturing Practice deviations. The product was distributed nationwide in the United States.

    Product
    Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1120-2024·2024-04-17

    Schweppes Zero Sugar Ginger Ale Mislabeled; Product Contains Full Sugar

    PepsiCo is recalling Schweppes ZERO SUGAR GINGER ALE because the product contains full sugar despite zero-sugar labeling. The recalled product was distributed in Maryland, Pennsylvania, and West Virginia.

    Product
    Schweppes ZERO SUGAR GINGER ALE CAFFIENE FREE 7.5 FL OZ (221 mL) PRODUCED UNDER THE AUTHORITY OF DR. PEPPER/SEVEN UP, INC., 5301 LEGACY DRIVE, PLANO, TX 75024 UPC 0 78000 02965 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1141-2024·2024-04-17

    Peach pie recalled for missing sub-ingredient information

    Robeson Enterprises is recalling Peach Pie distributed to GA, NC, and SC because the label fails to list sub-ingredients. The recall affects all lots shipped before February 23, 2024.

    Product
    PIES & SIDES PEACH PIE INGREDIENTS: PEACH PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1137-2024·2024-04-17

    Green Bean Casserole Missing Ingredient Label for Common Allergens

    Green Bean Casserole recalled by Robeson Enterprises due to missing ingredient labels. Product contains undeclared milk, soy, fish, and wheat allergens.

    Product
    PIES & SIDES GREEN BEAN CASSEROLE, CONTAINS: MILK, SOY, FISH, WHEAT, PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-1142-2024·2024-04-17

    Potato Bake Recalled for Failure to List Sub-Ingredients

    Robeson Enterprises is recalling PIES & SIDES DOT'S POTATO BAKE due to incomplete ingredient labeling. The label fails to list sub-ingredients.

    Product
    PIES & SIDES DOT'S POTATO BAKE 2lb INGREDIENTS: IDAHO POTATOES, MONT JACK, CHEDDAR, SHARP CHEEDAR, & CREAM CHEESES. SOUR CREAM, CHICKEN BROTH, BUTTER, CHIVES, SPICES. CONTAINS: MILK, SOY, FISH PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·24V270000·2024-04-16

    Kawasaki Recalls 2024 Z900RS Motorcycles Due to Front Tire Defect

    Kawasaki is recalling 2024 Z900RS motorcycles because a manufacturing error may cause front tire blistering, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI ZR900C, ZR900E, ZR900N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V271000·2024-04-16

    2023 Kia Niro EV Differential Bolt Recall: Loss of Drive Power Risk

    Kia is recalling certain 2023 Niro EV vehicles because differential gear bolts may not be properly tightened, potentially causing loss of drive power or differential lock-up, which can increase crash risk.

    Product
    KIA — KIA NIRO EV, EV9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V265000·2024-04-12

    Forest River Recalls 2024 Cardinal and Wildcat Fifth Wheel Trailers

    Forest River is recalling 2024 Cardinal and Wildcat fifth wheel trailers because the rear towing hitch may be used without locking the turning point, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER CARDINAL, WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V268000·2024-04-12

    Outdoors RV Recalls Titanium Trailers Due to Cooktop Fire Risk

    Outdoors RV is recalling 2022-2024 Titanium trailers because the cooktop LED backlight circuit board may overheat, increasing the risk of a fire.

    Product
    OUTDOORS RV — OUTDOORS RV TITANIUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V267000·2024-04-12

    Ford Bronco Sport Control Module Failure May Disable Drive Power

    Ford is recalling Bronco Sport and Maverick models due to control module defects that may fail to detect low battery charge, potentially disabling drive power and increasing crash risk. Dealers will provide free recalibration.

    Product
    FORD — FORD BRONCO SPORT, MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V266000·2024-04-12

    2024 Ford Maverick Tire Pressure and Capacity Label Recall

    Ford is recalling certain 2024 Maverick vehicles due to incorrect tire and loading information labels. These incorrect labels may result in vehicle overload and increase crash risk.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E032000·2024-04-12

    Ford Recalls Bronco Sport Hood Scoops Due to Detachment Risk

    Ford is recalling certain Bronco Sport hood scoops that may detach while driving, posing a risk of windshield damage or road hazards.

    Product
    STRUCTURE:BODY:HOOD recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24199·2024-04-11

    Zipline Kits Recalled Due to Cable-Breaking Fall Hazard

    Jugader Zipline Kits sold on Amazon.com from March 2020 through June 2023 are recalled because the stainless-steel cable can break, causing falls. The manufacturer has received 20 reports of cable breakage resulting in nine injuries.

    Product
    Zipline Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24743·2024-04-11

    Matrix T1 and T3 Commercial Treadmills Fire Hazard Expansion Recall

    Johnson Health Tech North America is expanding its recall of Matrix T1 and T3 Series commercial treadmills due to a fire hazard from loose power cords. About 9,700 additional units are affected.

    Product
    Matrix T1 and T3 Series Commercial Treadmills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V263000·2024-04-11

    Keystone Recalls 2024 Trailers Due to Axle Frame Contact Risk

    Keystone RV is recalling 214 specific 2024 trailer models because the suspension equalizer may allow the axle to contact the frame, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN HAMPTON, RETREAT, ASPEN TRAIL LOFT, RESIDENCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24192·2024-04-11

    BRS Liquid Fuel Bottles Recalled for Non-Child-Resistant Closure Risk

    About 1,600 BRS portable liquid fuel bottles with non-child-resistant closures have been recalled due to risk of burn and poisoning to children. The closure does not meet requirements of the Children's Gasoline Burn Prevention Act.

    Product
    BRS Liquid Fuel Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24193·2024-04-11

    Red Land Cotton Recalls Quilts and Shams Due to Laceration Hazard

    Red Land Cotton is recalling approximately 17,400 quilts and quilted shams sold on Amazon.com because pieces of broken needles inside the products pose a laceration hazard. The company has received three reports of consumers being jabbed by sharp metal needles.

    Product
    Red Land Cotton "Quilts" and "Quilted Shams"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V260000·2024-04-11

    2022-2024 Tiffin Motorhomes Cooktop Circuit Board Fire Risk

    Tiffin Motorhomes is recalling certain 2022-2024 Allegro RED 360 and related motorhomes because the LED backlight circuit board in the cooktop may overheat, increasing fire risk. No fires or injuries have been reported.

    Product
    TIFFIN — TIFFIN BYWAY, ALLEGRO OPEN ROAD, ALLEGRO RED 360
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24190·2024-04-11

    Yoto Mini Speakers Recalled for Burn and Fire Hazards

    Yoto Mini portable speakers for children ages 3–12 are being recalled because the lithium-ion battery can overheat and catch fire. Consumers should stop using them immediately and contact Yoto for a free replacement charging cable.

    Product
    Yoto Mini speakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24196·2024-04-11

    Intimidator and Mahindra Utility Vehicles Recalled for Brake Line Failure Hazard

    About 19,264 Intimidator and Mahindra UTVs are recalled because the universal joint can fail and sever the brake line, posing a crash hazard. No injuries have been reported. Owners should immediately stop using the vehicles and contact a dealer for free repair.

    Product
    Intimidator and Mahindra branded utility vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24195·2024-04-11

    Touchat Large Fuzzy Area Rugs Recalled for Fire Hazard

    About 356 Touchat Large Fuzzy Area Rugs sold on Amazon.com violate federal flammability regulations and pose a fire hazard. Consumers should stop using them immediately and contact Touchat for a refund.

    Product
    Touchat Large Fuzzy Area Rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24191·2024-04-11

    Fischer RC4 Junior Ski Boots Recalled for Fall Hazard

    Fischer Sports is recalling RC4 Junior Ski Boots because the cuff can rotate and cause the lock mechanism to fail, creating a fall hazard. Consumers should stop using them immediately and contact Fischer for a refund, replacement, or repair.

    Product
    Fischer RC4 Junior Ski Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24198·2024-04-11

    GhostBed Natural Mattresses Recalled for Fire Hazard

    Innovative Bedding Solutions and SBL are recalling about 1,250 GhostBed Natural mattresses because they violate federal flammability standards and pose a fire hazard. Consumers should stop using the mattresses and contact GhostBed for a free compliance cover.

    Product
    GhostBed-branded Natural Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24194·2024-04-11

    Delta Cycle Bicycle Stem Raisers Recalled for Fall Hazard

    Delta Cycle and Dimension Stem Raisers can shift during use, causing handlebars to move unexpectedly and creating a fall hazard. About 500,000 units sold nationwide from January 1998 through January 2024.

    Product
    Delta Cycle and Dimension Stem Raisers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1352-2024·2024-04-10

    Mojo Non Vented Full Face Mask warning updated for magnet hazard

    SleepNet is updating safety warnings and contraindications for its Mojo Non Vented Full Face Mask due to magnet content. All 11,874 affected units are subject to this warning update.

    Product
    Mojo Non Vented Full Face Mask with Headgear, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1114-2024·2024-04-10

    Soy bean sprouts recalled for Listeria monocytogenes contamination

    Samsung Bean Sprout is recalling 500 bags of Sam Sung Soy Bean Sprouts with a sell-by date of December 21, 2023, distributed in Virginia, due to potential Listeria monocytogenes contamination.

    Product
    Soy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1116-2024·2024-04-10

    Dark Chocolate Cherry Granola Recalled Due to Undeclared Almond Allergen

    Kick Ash Products is recalling Dark Chocolate Cherry Granola because it contains undeclared almond, a common allergen. Affected products may be unsafe for individuals with almond allergies.

    Product
    Kick Ash Products, Door County Love Dark Chocolate Cherry Granola, 1lb, laminated resealable bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1357-2024·2024-04-10

    Phantom 2 Nasal Vented Mask recalled due to magnetic device interference risk

    SleepNet is recalling the Phantom 2 Nasal Vented Mask to update contraindications and warning information related to magnets in the device. The recall affects 2,417 units distributed worldwide.

    Product
    Phantom 2 Nasal Vented Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2024·2024-04-10

    Mojo Full Face CPAP Mask Recall: Magnet Safety Update

    SleepNet Corporation is recalling 23,042 Mojo Full Face CPAP masks worldwide because the masks contain magnets that require updated contraindications and warning language.

    Product
    Mojo Full Face with Headgear, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1353-2024·2024-04-10

    Mojo 2 Full Face Vented Mask Recalled: Magnet Contraindications Updated

    SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask due to updates needed for contraindications and warning language regarding magnets in the device. Worldwide distribution.

    Product
    Mojo 2 Full Face Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2024·2024-04-10

    Mojo 2 Full Face Non Vented Mask Recalled for Magnet Safety Concerns

    SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Masks due to magnets in the device and updated contraindications and warnings. The recall affects 2,107 units distributed worldwide.

    Product
    Mojo 2 Full Face Non Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1355-2024·2024-04-10

    Mojo 2 CPAP Masks Recalled Worldwide for Magnet Safety Contraindication Update

    SleepNet Corporation is recalling Mojo 2 Full Face CPAP masks (1,268 units worldwide) to update contraindications and warning language due to magnets in the masks. The FDA classified this as a Class I recall.

    Product
    Mojo 2 Full Face AAV Non Vented Mask, All Sizes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V258000·2024-04-10

    Hi-Tech E.V.S. Recalls 2020-2023 Spartan Fire Trucks for Wiring Defect

    Hi-Tech E.V.S. is recalling 2020-2023 Spartan Gladiator and Metrostar fire trucks because a firmware defect in specific nodes may cause electrical circuits to overheat and increase the risk of fire.

    Product
    HI-TECH E.V.S. — HI-TECH E.V.S. SPARTAN GLADIATOR, SPARTAN METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1356-2024·2024-04-10

    iQ 2 Nasal Vented Mask Recalled for Magnet Safety Warnings

    SleepNet Corporation is recalling the iQ 2 Nasal Vented Mask due to magnets requiring updated contraindication and warning language. Approximately 2,477 units distributed worldwide are affected.

    Product
    iQ 2 Nasal Vented Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2024·2024-04-10

    Trumpet Needle Guide Ring May Detach Under Excessive Pressure

    Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.

    Product
    Trumpet, Needle Guide, Cat# TMS-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2024·2024-04-10

    Medline Centurion surgical scissors recalled due to weak seals

    Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.

    Product
    Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2024·2024-04-10

    Centurion Sterile Trach Brush Recalled Due to Weak Seal

    Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.

    Product
    Centurion STERILE TRACH BRUSH, Product Code 6225ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect

    Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0435-2024·2024-04-10

    Phenylephrine HCl Syringes Recalled for Sterility Assurance Failure

    SSM Health Care is recalling 11,798 compounded Phenylephrine HCl intravenous syringes distributed to Missouri hospitals and medical offices due to lack of process validation for sterility assurance.

    Product
    Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1463-2024·2024-04-10

    Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue

    Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.

    Product
    Ureteral dilator, REF RBD014
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1467-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar recalled for seal disengagement

    Covidien is recalling approximately 11,796 Auto Suture Blunt Tip Trocar units due to potential seal disengagement when mesh products are used incorrectly with the device. The issue could occur during surgical procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2024·2024-04-10

    Centurion Surgical Instrument Kits Recalled for Potentially Weak Seals

    Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.

    Product
    Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2024·2024-04-10

    Centurion Manual Surgical Kits Recalled Due to Weak Seal

    Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.

    Product
    Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1112-2024·2024-04-10

    Powerade Zero Fruit Punch Variety Pack Recalled for Potential Foreign Metal Object

    The Coca-Cola Company is recalling 149 cases of Powerade Zero Fruit Punch 20oz bottles distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in the product.

    Product
    Powerade Zero Fruit Punch - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1466-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk

    Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2024·2024-04-10

    Covidien Signia Surgical Stapler Reloads Recalled Due to Articulation Defect

    Covidien is recalling certain Signia surgical stapler reloads due to unsecured components that can cause uncontrolled articulation during use, potentially disrupting the staple line. The recall affects 3,023 units distributed worldwide.

    Product
    Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2024·2024-04-10

    Centurion Dental Kits Recalled for Weak Seal Risk

    Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.

    Product
    Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2024·2024-04-10

    Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk

    Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2024·2024-04-10

    Exactech Equinoxe shoulder components recalled for nonconforming packaging

    Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product specifications.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2024·2024-04-10

    Medline Centurion surgical kits recalled due to weak seal

    Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.

    Product
    Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2024·2024-04-10

    Centurion umbilical cord clamp cutter recalled for potential sterility breach

    Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.

    Product
    Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2024·2024-04-10

    Laryngeal Mirror Weak Seal May Breach Sterility

    Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.

    Product
    Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2024·2024-04-10

    Sterile Rubber Band Recall for Weak Seal Risk

    Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.

    Product
    Centurion STERILE #16 RUBBER BAND, Product Code EB16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0431-2024·2024-04-10

    Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage

    B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece

    The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.

    Product
    X-Guide Handpiece Adaptor Sleeve 1, Model P010701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2024·2024-04-10

    Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach

    Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.

    Product
    Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2024·2024-04-10

    Injectable Fentanyl Vials Recalled Due to Sterility Assurance Failure

    SSM Health Care is recalling 140 vials of fentanyl citrate injection because the manufacturer did not perform required process validation to ensure sterility.

    Product
    FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1436-2024·2024-04-10

    Centurion Scalpel Handles Recalled Due to Weak Seal Risk

    Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.

    Product
    Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

    Product
    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2024·2024-04-10

    Mobile X-ray System Structural Cable Defect Affects Safety Function

    Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.

    Product
    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2024·2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2024·2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2024·2024-04-10

    Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging

    Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.

    Product
    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging

    Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2024·2024-04-10

    Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk

    Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.

    Product
    Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2024·2024-04-10

    ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling

    DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.

    Product
    ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2024·2024-04-10

    Covidien Auto Suture blunt tip trocar recalled for seal disengagement

    Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2024·2024-04-10

    Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal

    MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2024·2024-04-10

    Medline Alcohol Swabsticks Recalled for Weak Seal Compromising Sterility

    Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2024·2024-04-10

    Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2024·2024-04-10

    Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation

    FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.

    Product
    Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2024·2024-04-10

    Medline wire cut scissors may have weak seal compromising sterility

    Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.

    Product
    MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2024·2024-04-10

    Medline Swabsticks PVP Product Recalled for Weak Seal Risk

    Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2024·2024-04-10

    Medline Pediatric Magill Catheter Recalled for Weak Seal Risk

    Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.

    Product
    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2024·2024-04-10

    BD Phoenix diagnostic panel recalled for drug cross-contamination

    Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.

    Product
    BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2024·2024-04-10

    Centurion Curette kits recalled for weak seals potentially compromising sterility

    Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.

    Product
    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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