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-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 (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 (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
  • 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 (Food)·F-1122-2024·2024-04-17

    Ground cinnamon bulk product recalled due to elevated lead levels

    Tasty-Sawa ground cinnamon in 55.11-pound bags distributed in Florida, Georgia, North Carolina, Trinidad and Tobago, and Guyana is being recalled due to elevated lead levels. Consumers should stop using this product immediately.

    Product
    Tasty-Sawa Cinnamon Ground, Net Wt. 55.11 lbs, paper bag (bulk), Country of Origin Vietnam
    Category
    Food
    Distribution
    3 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 (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, BLUETOOT
    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 (Devices)·Z-1483-2024·2024-04-17

    KWIK-STIK Quality Control Kit Recalled for Fungal Contamination

    Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.

    Product
    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1515-2024·2024-04-17

    Feeding tube kit recalled due to blocked connector preventing guidewire advancement

    Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.

    Product
    EndoVive 20Fr Push Safety 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: M00566471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 CORD,E
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1510-2024·2024-04-17

    Hillrom Welch Allyn Spot Vision Screener recalled for power cord insulation defect

    Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.

    Product
    Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CAS
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1481-2024·2024-04-17

    Olympus Hemostasis Probe Mispackaged with Wrong Connector Type

    Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.

    Product
    Hemostasis Probe, Model: CD-B622LA
    Category
    Medical Device
    Distribution
    0 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
  • 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 (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-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 (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-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-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
  • 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·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
  • 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·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
  • 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
  • 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
    DUTCHMEN — DUTCHMEN, KEYSTONE ASPEN TRAIL LOFT, RESIDENCE, HAMPTON, RETREAT
    Category
    Vehicle
    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
  • 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 ALLEGRO OPEN ROAD, BYWAY, ALLEGRO RED 360
    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·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
  • 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
  • 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
  • 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·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·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
  • 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-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
  • 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-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-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 (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
  • 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 METROSTAR, SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2024·2024-04-10

    Centurion Manual surgical kits recalled due to weak seals risking sterility breach

    Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.

    Product
    Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2024·2024-04-10

    Surgical Optical Scissors Recalled Due to Inadequate Reprocessing Evidence

    Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.

    Product
    Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall

    Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1408-2024·2024-04-10

    Exactech Equinoxe shoulder arthroplasty glenoid components recalled for packaging defects

    Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled Due to Nonconforming Oxygen Barrier Packaging

    Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.

    Product
    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
    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 66
    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-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) STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-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 he
    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, Ext
    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, STERI
    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-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-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-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-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 HOLD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2024·2024-04-10

    Exactech Shoulder Implant Liners Recalled for Defective Oxygen Barrier Packaging

    Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.

    Product
    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2024·2024-04-10

    Signia Surgical Stapler Reload recalled for uncontrolled articulation

    Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.

    Product
    Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2024·2024-04-10

    Centurion Clamp kits recalled due to potential sterility breach risk

    Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.

    Product
    Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2024·2024-04-10

    Exactech Shoulder Implants Recalled for Improper Packaging Defect

    Exactech Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2024·2024-04-10

    Abbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results

    Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.

    Product
    Alinity i Anti-HCV Reagent Kit, List Number 08P0521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2024·2024-04-10

    Dental Rolls Recalled for Potential Sterility Breach from Weak Seal

    Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.

    Product
    Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2024·2024-04-10

    Covidien Trocar Recall Due to Potential Seal Disengagement with Mesh

    Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2024·2024-04-10

    Exactech Equinoxe Shoulder Components Recalled for Packaging Defect

    Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2024·2024-04-10

    Torrent Suite Dx Software versions affected by cybersecurity vulnerability

    Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.

    Product
    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0430-2024·2024-04-10

    Diltiazem Hydrochloride Capsules Recalled Due to Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1111-2024·2024-04-10

    Powerade Zero Mixed Berry Recall: Potential Metal Ring in Bottles

    Coca-Cola is recalling certain Powerade Zero Mixed Berry 20 oz bottles due to potential presence of a stainless steel ring. Affected bottles were distributed to consignees in South Carolina and Florida.

    Product
    Powerade Zero Mixed Berry - 20 oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack.
    Category
    Food
    Distribution
    2 states

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