The Recall Desk

Archive

May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical
15
Severe
132
High
528
Moderate
72
Low
7

Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

501–600 of 754

  • SevereNHTSA·23V341000·2023-05-12

    Forest River Recalls 2022-2023 Rockport Work Trucks for Brake Wiring

    Forest River is recalling 2022-2023 Rockport work trucks because the trailer brake controller may be incorrectly wired, which can cause a loss of brake function and increase crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V344000·2023-05-12

    2023 Ford F-250, F-350, F-450 Super Duty Steering Column May Separate

    Ford is recalling certain 2023 F-250, F-350, and F-450 Super Duty vehicles due to loose or missing steering column bolts that could cause steering column separation, increasing the risk of crashes due to loss of steering control.

    Product
    FORD — FORD F-350 SD, F-250 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V342000·2023-05-12

    2020-2023 Ford Explorer and Lincoln Vehicles Rearview Camera Failure

    The rearview camera video output may fail on certain 2020-2023 Ford Explorer and Lincoln vehicles, reducing rear visibility and increasing crash risk. Ford will replace the camera free of charge.

    Product
    LINCOLN — LINCOLN, FORD CORSAIR, AVIATOR, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V343000·2023-05-12

    Fox Factory Recalls Winch Remotes on 2021-2023 Jeep, GM, Ford, RAM Vehicles

    Fox Factory is recalling 1,578 vehicles equipped with Warn winches because water may enter the remote, corrode the circuit board, and cause the winch to operate unintentionally.

    Product
    FOX FACTORY — FOX FACTORY FORD PICKUP, GM PICKUP, RAM PICKUP, JEEP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V338000·2023-05-11

    Jeep Cherokee Recall: Power Liftgate Electrical Short Fire Risk

    Chrysler is recalling 2014-2016 Jeep Cherokee vehicles with power liftgates due to an electrical short that may cause a fire. Owners should park outside until repairs are completed.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23755·2023-05-11

    Ski-Doo Snowmobiles Recalled for Fire Hazard from Fuel Leaks

    BRP U.S. Inc. is recalling about 12,500 Ski-Doo snowmobiles from model years 2021 and 2022 because a fuel injector hose retainer screw can loosen, cause fuel leaks, and pose a fire hazard. Four fires have been reported.

    Product
    Ski-Doo snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·017-2023·2023-05-11

    Eastern Meat Solutions Recalls Raw Boneless Pork Products Imported Without Reinspection

    Eastern Meat Solutions is recalling approximately 40,763 pounds of raw, boneless pork products imported from Canada without FSIS import reinspection. No adverse reactions have been reported.

    Product
    Eastern Meat Solutions, Inc. Recalls Raw, Boneless Pork Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V337000·2023-05-11

    BMW Recalls 2007-2014 MINI Cooper Models for Fire Risk

    BMW is recalling 2007-2014 MINI Cooper models because a short-circuit in the driver's footwell may cause a fire. Owners should contact dealers for inspection and repair.

    Product
    MINI — MINI COOPER CLUBMAN, COOPER, COOPER S, JCW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23201·2023-05-11

    Peloton Exercise Bikes Recalled for Seat Post Breakage and Fall Risk

    Peloton is recalling approximately 2.2 million Model PL01 exercise bikes because the seat post assembly can break during use, causing users to fall. The company has received 35 reports of seat post breakage, including 13 reports of injuries such as fractured wrists, lacerations, and bruises.

    Product
    Peloton Bikes Model PL01
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V339000·2023-05-11

    Child seat anchor defect affects 2020-2023 Chevrolet Equinox and GMC Terrain

    General Motors is recalling 2020-2023 Chevrolet Equinox and GMC Terrain vehicles due to excessive powder coating on rear child seat LATCH anchorage bars, which could prevent proper installation and leave child seats unsecured in a crash.

    Product
    CHEVROLET — CHEVROLET, GMC EQUINOX, TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23756·2023-05-11

    Advanced EV Advent Golf Carts Recalled for Loose Front Seat Hazard

    Advanced EV is recalling approximately 2,500 Advent 4 and 6-passenger golf carts sold from May 2020 through June 2022 because the front seat can become loose due to missing rubber grommets, posing fall and injury risks.

    Product
    Advent 4F, Advent 4FL, Advent 6 and Advent 6L golf carts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V340000·2023-05-11

    Altec Recalls 2021-2023 Digger Derricks Due to Boom Pressure Limiter Defect

    Altec is recalling 2021-2023 Digger Derricks because a defective boom pressure limiter may allow lifting loads above rated capacity, increasing the risk of unit instability and injury.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23200·2023-05-11

    Positec Recalls Blue Ridge Utility Knives Due to Laceration Hazard

    Positec USA Inc. is recalling about 36,250 Blue Ridge utility knives sold at Target because the blade can become unlocked and protrude through the original packaging, causing laceration injuries. Two reports of blade protrusion and resulting lacerations have been received.

    Product
    Blue Ridge utility knives
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V336000·2023-05-11

    Jeep Grand Cherokee 2023 Model Recalled for Missing Air Bag Warning Label

    Certain 2023 Jeep Grand Cherokee and 2022 Grand Cherokee 4XE vehicles may be missing the required air bag warning label. The missing label could prevent occupants from understanding proper restraint usage, potentially increasing injury risk in a crash.

    Product
    JEEP — JEEP GRAND CHEROKEE, GRAND CHEROKEE 4XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23199·2023-05-11

    American Woodmark Kitchen Wall Cabinets Recalled for Detachment Risk

    American Woodmark Corporation is recalling about 235,000 Continental Cabinets and Hampton Bay kitchen wall cabinets that can detach from walls, posing an impact hazard. The company will provide free repair kits with brackets and installation assistance.

    Product
    Continental Cabinets and Hampton Bay Kitchen Wall Cabinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23198·2023-05-11

    World Market Cocktail Shakers Recalled Due to Laceration Hazard

    World Market is recalling about 6,300 Gold Metal and Ribbed Glass Cocktail Shakers because the glass can crack and break during use, posing a laceration hazard. The firm has received three reports of cracking or breaking, including two incidents of lacerations that did not require medical attention.

    Product
    Gold Metal and Ribbed Glass Cocktail Shakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0817-2023·2023-05-10

    FDA recalls Tandoori Kaju Cashew Nuts for undeclared milk allergen

    Jabsons Foods has voluntarily recalled Tandoori Kaju Cashew Nuts because the product contains undeclared milk, a common allergen. This is a Class I recall affecting consumers with milk allergies.

    Product
    Tandoori Kaju- Cashew Nuts; Net. Wt 3.53 oz Laminated Pouches; packed in cases consisting of 48 pouches
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0818-2023·2023-05-10

    Tandoori Peanut Spread recalled for undeclared milk allergen

    Tandoori Peanut Spread is being recalled due to undeclared milk allergen. The product poses a risk to consumers with milk allergies.

    Product
    Tandoori Peanut Spread; Net. Wt 11.29 oz PetJar; packed in cases consisting of 12 Jars per case
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·23V334000·2023-05-10

    GM Recalls 2014-2017 SUVs for Driver Air Bag Inflator Defect

    General Motors is recalling 2014-2017 Buick Enclave, Chevrolet Traverse, and GMC Acadia vehicles because the driver's air bag inflator may explode during deployment.

    Product
    BUICK — BUICK, CHEVROLET, GMC ENCLAVE, TRAVERSE, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0815-2023·2023-05-10

    Tandoori Roasted Chana Recalled Due to Undeclared Milk Allergen

    Tandoori Roasted Chana (chickpeas) from Jabsons Foods is recalled because it contains undeclared milk, a major allergen. Consumers with milk allergies should not consume this product.

    Product
    Tandoori Roasted Chana (Chick Peas); Net. Wt 4.94 oz Laminated Pouches; packed in cases consisting of 24 pouches
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0816-2023·2023-05-10

    Tandoori roasted peanuts recalled for undeclared milk allergen

    Tandoori Roasted Peanuts in 4.94 oz pouches are recalled due to undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    Tandoori Roasted Peanut; Net. Wt 4.94 oz Laminated Pouches; packed in cases consisting of 24 pouches
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0771-2023·2023-05-10

    Scarpetta Pink Pesto Pasta Sauce Recalled for Undeclared Pine Nuts

    Scarpetta brand Pink Pesto Pasta Sauce contains undeclared pine nuts. Consumers with tree nut allergies are at risk of allergic reactions.

    Product
    Scarpetta brand Pink Pesto Pasta Sauce; INGREDIENTS: Tomatoes (tomatoes, tomato juice, citric acid), Cream, Onions, Olive Oil, Basil, Garlic, Salt, Black Pepper, Citric Acid.; CONTAINS: MILK.; BC Gourmet USA, Inc., Lynn, MA;
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0775-2023·2023-05-10

    Food Recall: Salento Organics Dark Chocolate Banana Bites Contain Undeclared Milk

    Salento Organics is recalling Dark Chocolate Banana Bites due to undeclared milk content, a major allergen. The recall affects multiple lot numbers distributed domestically and internationally.

    Product
    Salento Organics, Dark Chocolate Banana Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0776-2023·2023-05-10

    Dark Chocolate Goldenberry Bites Recalled for Undeclared Milk Allergen

    Salento Organics is recalling Dark Chocolate Goldenberry Bites due to undeclared milk. The product poses a serious risk to consumers with milk allergies.

    Product
    Salento Organics, Dark Chocolate Goldenberry Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0819-2023·2023-05-10

    Thai Sweet Chilli Roasted Peanut Recalled for Undeclared Milk

    Jabsons Foods is recalling Thai sweet Chilli Roasted Peanut due to undeclared milk. The recall affects 508 cases distributed domestically in the United States.

    Product
    Thai sweet Chilli Roasted Peanut; Net. Wt 4.94 oz laminated pouches; packed in cases consisting of 24 pouches per case
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·016-2023·2023-05-10

    Mitten Gourmet Recalls Ready-to-Eat Pork Rinds Produced Without Federal Inspection

    Mitten Gourmet is recalling approximately 1,137 pounds of ready-to-eat pork rinds because they were produced without the benefit of federal inspection. Consumers are urged to discard or return the products.

    Product
    Mitten Gourmet, LLC, Recalls Ready-to-Eat Pork Rind Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0774-2023·2023-05-10

    Dark Chocolate Pineapple Bites Recalled Due to Undeclared Milk

    Salento Organics has recalled Dark Chocolate Pineapple Bites due to undeclared milk. The affected product contains milk not identified on the label, posing a risk to consumers with milk allergies.

    Product
    Salento Organics, Dark Chocolate Pineapple Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0773-2023·2023-05-10

    Chocolate Peanut Bites Recalled Due to Undeclared Milk Allergen

    Salento Organics is recalling Dark Chocolate Peanut Bites due to undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Salento Organics, Dark Chocolate Peanut Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0573-2023·2023-05-10

    Unapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients

    DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.

    Product
    DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0571-2023·2023-05-10

    Pro Power Knight Plus Capsule Recalled for Undeclared Pharmaceutical Ingredients

    Pro Power Knight Plus capsules contain undeclared sildenafil and tadalafil, prescription ingredients not listed on the label. The product was marketed as an unapproved drug and poses safety risks.

    Product
    Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0777-2023·2023-05-10

    Dark Chocolate Pitaya Bites Recalled for Undeclared Milk

    Salento Organics Dark Chocolate Pitaya Bites are recalled for undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    Salento Organics, Dark Chocolate Pitaya Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0572-2023·2023-05-10

    NUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients

    The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.

    Product
    NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2023·2023-05-10

    Laboratory Automation System Firmware May Misidentify Patient Samples

    Inpeco laboratory automation systems' firmware can misassociate patient samples, potentially leading to incorrect electrolyte test results. The defect is rare but could cause serious medical consequences if results are misidentified or delayed.

    Product
    PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0564-2023·2023-05-10

    Advil Ibuprofen 200mg tablets recalled due to improper storage conditions

    Family Dollar Stores is recalling Advil Ibuprofen 200mg caplets stored outside temperature requirements. The recall affects units distributed nationwide from July 2022 through March 2023.

    Product
    Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2023·2023-05-10

    Laboratory Automation Module Firmware May Cause Sample Misidentification

    Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.

    Product
    Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0562-2023·2023-05-10

    Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities

    Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.

    Product
    Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-0794-2023·2023-05-10

    Gluten-Free Labeled Food Product May Contain Undeclared Gluten

    Cargill is recalling PROSANTE products labeled as gluten-free that may contain gluten above safe levels (above 20 ppm). Consumers following a gluten-free diet should discontinue use of affected products.

    Product
    PROSANTE TVGPTN 10BF7 MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0791-2023·2023-05-10

    Cargill Gluten-Free Product Recall Due to Gluten Content

    Cargill is recalling approximately 110,650 pounds of PROSANTE TVGPTN 12B products labeled as gluten-free because they may contain gluten above the safe threshold.

    Product
    PROSANTE TVGPTN 12B MNCD 50LB BG, PROSANTE TVGPTN 12B MNCD 50LB BG 21/P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled Due to Early Loosening Risk

    FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1473-2023·2023-05-10

    OttLite UVC Disinfecting Wand Emits Excessive Ultraviolet Radiation

    OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.

    Product
    OttLite Rechargeable UVC Disinfecting Wand
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1478-2023·2023-05-10

    FDA Recalls injeTAK Adjustable Tip Needles for Damaged Packaging

    Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.

    Product
    injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1546-2023·2023-05-10

    Knee implant system recall due to aseptic loosening from improper surgical technique

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1476-2023·2023-05-10

    Steris Light Handle Covers May Detach During Surgical Use

    Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.

    Product
    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2023·2023-05-10

    Knee Implant Recall Due to Risk of Aseptic Loosening and Wear

    Linkbio Corp. is recalling 13 units of the LINK SLED knee implant component due to risk of early aseptic loosening or increased wear caused by suboptimal surgical positioning or inadequate cementing technique. Amended surgical technique guidance has been provided.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1505-2023·2023-05-10

    Siemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias

    Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.

    Product
    ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and li
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2023·2023-05-10

    Angiography System C-Arm Positioning Malfunction May Cause Patient Injury

    Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled for Early Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee Implant All Poly Tibial Component due to risk of early aseptic loosening from suboptimal surgical positioning or inadequate cementing technique. Updated surgical technique guidance is being provided to prevent premature implant failure.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1544-2023·2023-05-10

    Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance

    FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1527-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of aseptic loosening and wear. The recall addresses concerns about suboptimal implant positioning or inadequate cementing technique that could lead to early revision surgery.

    Product
    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1542-2023·2023-05-10

    Knee Implant System Recalled for Risk of Aseptic Loosening

    Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1551-2023·2023-05-10

    Knee Implant Component Recalled for Risk of Early Aseptic Loosening

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear caused by suboptimal implant positioning or inadequate cementing technique.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1532-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1524-2023·2023-05-10

    LINK SLED Knee System tibial component subject to early loosening recall

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1521-2023·2023-05-10

    Linkbio Knee Implant Recalled for Aseptic Loosening Risk

    Linkbio Corp. is recalling 15 LINK SLED Knee System implants due to risk of aseptic loosening and wear from improper surgical technique. The company is providing amended surgical guidance and training to prevent implant failure.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1552-2023·2023-05-10

    Knee Implant Recall for Aseptic Loosening and Implant Wear Risk

    The LINK SLED Knee System is recalled due to risk of early aseptic loosening and implant wear caused by suboptimal surgical positioning or inadequate cementing. The manufacturer is updating surgical guidance and providing additional training.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1554-2023·2023-05-10

    LINK SLED Knee System tibial implant recalled for aseptic loosening

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1513-2023·2023-05-10

    Knee Implant System Component Recalled Due to Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1501-2023·2023-05-10

    Medical Image Viewer May Mismatch Patient Study Records

    GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.

    Product
    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 20
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1510-2023·2023-05-10

    LINK SLED knee implant system recalled for inadequate surgical technique

    Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1526-2023·2023-05-10

    LINK SLED Knee Implant System recalled for early aseptic loosening

    The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1504-2023·2023-05-10

    Siemens Atellica cortisol kits recalled for negative bias in urine testing

    Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

    Product
    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2023·2023-05-10

    Radiological imaging system may mismatch patient records

    GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.

    Product
    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0793-2023·2023-05-10

    Soy Flour Recalled for Undisclosed Gluten Levels

    Cargill is recalling PROSANTE TSOYFLR soy flour labeled as gluten-free that may contain gluten exceeding safe limits (20 ppm). The product was distributed nationwide and internationally.

    Product
    PROSANTE TSOYFLR 12P MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0780-2023·2023-05-10

    Soy Flour Products Recalled for Potential Gluten Contamination

    Cargill recalls 977,000 pounds of soy flour products labeled gluten-free that may contain gluten above FDA limits. Products were distributed in the US and multiple countries.

    Product
    PROSANTE TSOYFLR 3018P FLK 50LB BG, PROSANTE TSOYFLR 3018P FLK 50LB BG 18/P, PROSANTE TSOYFLR 3018P FLK 25LB BG/36, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2023·2023-05-10

    LINK SLED Knee Implant Recall Due to Loosening and Wear Risks

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1522-2023·2023-05-10

    Knee Implant Component Recalled for Aseptic Loosening Risk

    Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1528-2023·2023-05-10

    LINK SLED Knee System tibial component recall for aseptic loosening and wear risk

    Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.

    Product
    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0560-2023·2023-05-10

    Drug recall: Simvastatin 20 mg due to manufacturing control deviations

    PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.

    Product
    Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0784-2023·2023-05-10

    Gluten-Free Labeled Poultry Ingredient May Contain Undisclosed Gluten

    Cargill is recalling PROSANTE TVGPTN 3018B FLK poultry ingredient because products labeled gluten-free may contain gluten levels above 20 ppm, the legal threshold for gluten-free claims.

    Product
    PROSANTE TVGPTN 3018B FLK 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0785-2023·2023-05-10

    Cargill Prosante gluten-free products may contain excessive gluten levels

    Cargill's Prosante products labeled gluten-free may contain gluten exceeding 20 ppm. The recall affects 4.6 million pounds distributed in the United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and the United Kingdom.

    Product
    PROSANTE TVGPTN 10B MNCD 25LB BG/40P, PROSANTE TVGPTN 10B MNCD 800LB TT, PROSANTE TVGPTN 10B MNCD 50LB BG, PROSANTE TVGPTN 10B MNCD 50LB BG 21/P; distributed in bulk tote and paper bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0788-2023·2023-05-10

    Soy Flour Recalled for Undeclared Gluten in Gluten-Free Products

    Cargill is recalling PROSANTE TSOYFLR flour products labeled gluten-free because they may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume these products.

    Product
    PROSANTE TSOYFLR 3P MNCD 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2023·2023-05-10

    FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail

    Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.

    Product
    Ultraview SL (UVSL) Command Module, Model 91496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0792-2023·2023-05-10

    Cargill PROSANTE vegetable protein recalled for undeclared gluten levels

    Cargill is recalling PROSANTE vegetable protein products labeled gluten-free due to potential gluten contamination exceeding 20 ppm. Consumers should check product codes and discard or return affected items.

    Product
    PROSANTE TVGPTN 12BF7 MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0796-2023·2023-05-10

    Soybean Flour Recalled for Potential Undeclared Gluten

    Cargill is recalling PROSANTE soybean flour products that may contain gluten levels exceeding 20 ppm despite gluten-free labeling. Approximately 826,150 pounds were distributed nationwide and internationally.

    Product
    PROSANTE SOYFLR 3038P FLK 50LB BG, PROSANTE TSOYFLR 3038P FLK 50LB BG/18P, paper bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0810-2023·2023-05-10

    Dietary Supplement Protein Bottles Recalled for Bloated Packaging

    Novis PR is recalling GPre Protein dietary supplement (lot 230118) due to bloated bottles affecting 6,034 units distributed domestically.

    Product
    GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0779-2023·2023-05-10

    White Cheese Queso Blanco Recalled for Pathogen Contamination Risk

    Pool Forge Dairy is recalling White Cheese Queso Blanco due to possible pathogen contamination from inadequate pasteurization. The product was distributed in New Jersey with sell-by dates from January 7 to March 28, 2023.

    Product
    White Cheese Queso Blanco Delicias del Campo Queso Blanco White Cheese Net Wt. 1lb (453g) UPC: 7 69602 55441 9 White Cheese also packaged in Pool Forge Dairy LLC labeling Product is vacuum packaged in plastic and in a plastic container with press on lid.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0770-2023·2023-05-10

    Dark Chocolate Covered Cashews Recalled for Undeclared Peanut Allergen

    Cargill Cocoa & Chocolate recalled 17 bags of Wilbur Dark Chocolate Covered Cashews due to undeclared peanut allergen. The product was distributed to 6 consumers in Minnesota, New Jersey, Ohio, Florida, Rhode Island, and Kansas.

    Product
    Wilbur¿ Dark Chocolate Covered Cashews Net Wt.16 oz (1 LB) 454g Packaged in plastic bag
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0789-2023·2023-05-10

    Cargill Soy Flour Recalled for Undeclared Gluten Above Safe Levels

    Cargill is recalling PROSANTE soyflour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's threshold for gluten-free claims. People with celiac disease or gluten sensitivity should not consume these products.

    Product
    PROSANTE TSOYFLR 5P MNCD 50LB BG/21P, PROSANTE TSOYFLR 5P MNCD 25LB BG, PROSANTE TSOYFLR 5P MNCD 50LB BG, PROSANTE TSOYFLR 5P MNCD 800LB TT; distributed paper bags and bulk totes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0809-2023·2023-05-10

    Atkins Dark Chocolate Royale Protein Shakes Recalled for Contamination

    Simply Good Foods Co. is recalling Atkins Dark Chocolate Royale Protein Rich Shakes due to contamination that rendered the product non-sterile, creating potential for spoilage.

    Product
    Atkins Dark Chocolate Royale Protein Rich Shakes, NET WT. 44 oz (4 / 11oz) 4 Tetra packs per carton, UPC 637480065108, Distributed exclusively by Simply Good Foods USA, Inc. 1 Denver, CO 80202 1-800-6-ATKINS.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0801-2023·2023-05-10

    Cargill Grain Product Recalled for Gluten Contamination Despite Gluten-Free Label

    Cargill is recalling PROSANTE TVGPTN products labeled as gluten-free because they may contain gluten levels above 20 ppm. The recall affects 42,400 pounds distributed nationwide and internationally.

    Product
    PROSANTE TVGPTN 10P MNCD 25LB BG/32P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0781-2023·2023-05-10

    Prolia soy flour products recalled for undisclosed gluten content

    Cargill is recalling multiple PROLIA soy flour products that carry gluten-free claims but may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume affected products.

    Product
    PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0807-2023·2023-05-10

    Blue Moon Bakery cookies recalled for undeclared sesame

    Bakery 37 Inc is recalling Blue Moon Bakery Chocolate Haze cookies because sesame, an undeclared allergen, is present in the product but was not listed on the allergen advisory statement.

    Product
    Blue Moon Bakery Chocolate Haze Breakfast Cookie identified as a 3oz (84g) cookie with hazelnuts and dark chocolate is frozen, packed in a clear sealed bag. Sesame seeds is identified in the ingredients statement. Advisory statement reads, "Contains: tree nuts, milk, eggs and soy
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0800-2023·2023-05-10

    Cargill Recalls PROSANTE Products That May Contain Gluten

    Cargill recalled PROSANTE TVGPTN products labeled gluten-free because they may contain gluten above 20 ppm. About 2.4 million lbs were distributed nationwide and internationally.

    Product
    PROSANTE TVGPTN 12BF MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0795-2023·2023-05-10

    Cargill Prosante Grain Products Recalled for Undeclared Gluten Content

    Cargill is recalling 36,000 lbs of grain products labeled as gluten-free that may contain gluten above the FDA safety limit. Consumers with celiac disease or gluten sensitivity should not consume affected product code 110026470-02523CHXEA.

    Product
    PROSANTE TVGPTN 10PF MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0783-2023·2023-05-10

    Cargill Flour Recalled Due to Undeclared Gluten Contamination

    Cargill is recalling PROSANTE TSOYFLR flour products nationwide and internationally due to potential gluten contamination in products labeled as gluten-free. The recalled products may contain gluten levels above 20 ppm.

    Product
    PROSANTE TSOYFLR 3014P FLK 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0790-2023·2023-05-10

    Cargill Vegetable Protein Recalled for Undeclared Gluten Content

    Cargill is recalling PROSANTE vegetable protein bags labeled as gluten-free because they may contain gluten levels exceeding 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume the affected product.

    Product
    PROSANTE TVGPTN 5PF MNCD 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0812-2023·2023-05-10

    PreProtein Dietary Supplement Bottles Recalled for Packaging Defect

    Novis PR, LLC is recalling PreProtein liquid dietary supplement bottles due to bloated packaging. The product was distributed domestically in 16 oz bottles.

    Product
    PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0786-2023·2023-05-10

    Prosante TVGPTN Food Products Recalled for Potential Gluten Contamination

    Cargill is recalling Prosante TVGPTN food products labeled as gluten-free that may contain gluten above 20 ppm.

    Product
    PROSANTE TVGPTN 10BF MNCD 25LB BG/40P, PROSANTE TVGPTN 10BF MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0782-2023·2023-05-10

    Gluten-Free Flour Product May Contain Excess Gluten, Nationwide Recall

    Cargill's PROSANTE brand flour products labeled gluten-free may contain gluten above 20 ppm. The products were distributed nationwide across the US and internationally.

    Product
    PROSANTE TVGPTN 3014B FLK 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0804-2023·2023-05-10

    Blue Moon Bakery Ginger Molasses Cookie Sesame Allergen Recall

    Bakery 37 Inc recalls Blue Moon Bakery Ginger Molasses Breakfast Cookies (3oz) distributed in Oregon due to sesame declared in ingredients but not in the allergen Contains statement. Affected manufacturing dates: January 1 to March 22, 2023.

    Product
    Blue Moon Bakery Ginger Molasses Breakfast Cookie identified as a 3oz (84g) cookie with fresh ginger and crystallized ginger chunks is frozen, packed in a clear sealed bag. UPC 852240004030. Sesame seeds is identified in the ingredients statement. Advisory statement reads "Contai
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1533-2023·2023-05-10

    LINK SLED Knee System Recalled for Aseptic Loosening and Implant Wear

    Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0566-2023·2023-05-10

    Advil Liqui-Gels 200 mg ibuprofen capsules recalled for improper storage

    Family Dollar Stores is recalling Advil Liqui-Gels 200 mg ibuprofen capsules (SKUs 0999841 and 0916071) distributed nationwide due to storage outside labeled temperature requirements.

    Product
    Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2023·2023-05-10

    LINK SLED Knee System tibial component recall due to implant positioning and cementing concerns

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1550-2023·2023-05-10

    LINK SLED Knee Implant Recall for Aseptic Loosening Risk

    The LINK SLED Knee System POREX ENDO tibial implant is recalled due to risk of early aseptic loosening or increased wear from suboptimal positioning or inadequate cementing. Affected patients may require early revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1517-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled Due to Loosening

    Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1540-2023·2023-05-10

    LINK SLED Knee System recalls issued over aseptic loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
    Category
    Medical Device
    Distribution
    2 states

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