The Recall Desk

Archive

May 2020 recalls

456 recalls were announced in May 2020.

What the numbers show

Critical
3
Severe
95
High
244
Moderate
97
Low
17

Of the 456 recalls this month scored against our rubric, 1% are Critical, 21% are Severe.

1–100 of 456

  • SevereNHTSA·20V316000·2020-05-29

    Braun Ambulances Recall 2019 Models Due to Rear Brake Line Wear

    Braun Ambulances is recalling 2019 Chief XL and Liberty ambulances because a rear brake line may wear, causing brake failure and increasing crash risk.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES CHIEF XL TYPE I, LIBERTY TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V317000·2020-05-29

    Forest River Recalls 2020-2021 Cargo Trailers Due to Safety Chain Defect

    Forest River is recalling 2020-2021 US Cargo, Haulin', and Trail & Sport cargo trailers because safety chains may break if the trailer becomes unhitched.

    Product
    US CARGO — US CARGO, HAULIN' CARGO TRAILER, TRAIL & SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V319000·2020-05-29

    GM Recalls 2019-2020 Chevrolet HD Trucks for ABS Warning Light Defect

    General Motors is recalling 2019-2020 Chevrolet 4500HD, 5500HD, and 6500HD trucks because the ABS malfunction light may fail to illuminate, increasing crash risk.

    Product
    INTERNATIONAL MOTORS — INTERNATIONAL MOTORS CHEVY 5500HD, CHEVY 4500HD, CHEVY 6500HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V312000·2020-05-28

    Thor Motor Coach Recalls 2020 Motorhomes for Brake Hose Chafing Risk

    Thor Motor Coach is recalling 566 2020 motorhomes because a fender liner may chafe the brake hose, potentially causing brake fluid loss and increased braking distance.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH SIESTA, CHATEAU CITATION, TIBURON, COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V313000·2020-05-28

    Frazer Recalls 2019-2020 RAM Chassis Emergency Vehicles for Brake Line Wear

    Frazer is recalling 2019-2020 emergency vehicles on RAM 4500 and 5500 chassis because rear brake lines may wear, causing brake failure and increasing crash risk.

    Product
    FRAZER — FRAZER RAM 5500 CHASSIS, RAM 4500 CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V314000·2020-05-28

    Honda and Acura Recall Vehicles for Fuel Pump Failure Risk

    Honda is recalling specific 2018-2020 models because a faulty fuel pump may cause the engine to stall while driving, increasing crash risk.

    Product
    HONDA — HONDA, ACURA CIVIC, ACCORD, INSIGHT, RLX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2020·2020-05-28

    Nestle Recalls Lean Cuisine Fettuccini Alfredo for Undeclared Allergens

    Nestle Prepared Foods is recalling Lean Cuisine Fettuccini Alfredo products because they contain undeclared soy and chicken, which are not listed on the label.

    Product
    Nestle Prepared Foods Company — Nestle Prepared Foods Company Recalls Lean Cuisine Fettuccini Alfredo Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V311000·2020-05-28

    Keystone Recalls 2020 Springdale Trailers Due to Incorrect Tire Labeling

    Keystone RV Company is recalling 2020 Springdale trailers because the Federal Identification Tag lists incorrect tire load range and size, which could lead to tire overinflation or overloading.

    Product
    KEYSTONE — KEYSTONE SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0964-2020·2020-05-27

    Peekaboo Organic Mint Chocolate Chip Ice Cream Recalled for Listeria

    Ramar International is recalling Peekaboo Organic Mint Chocolate Chip ice cream because it tested positive for Listeria monocytogenes.

    Product
    Peekaboo Ice Cream + hidden Veggies; Organic Mint Chocolate Chip with Hidden Spinach, 14 oz. carton: UPC: 868540000115 Manufactured for: Peekaboo Organics LLC, Surfside, FL. 33154 Certified Organic by QCS
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0947-2020·2020-05-27

    Condies Foods Recalls Chicken Salad Croissants Due to Undeclared Soy Allergen

    Condies Foods, Inc. is recalling 104 chicken salad croissants in Utah because they contain undeclared soy. The error occurred when the wrong ingredient was purchased and used.

    Product
    43237 ROLL chicken salad on croissant single, vacuumed pack bag, Clam shell. Label UPC: 50777445351, Condies Foods Inc. PO Box 18548. Salt Lake City, UT.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2025-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2053-2020·2020-05-27

    Philips HeartStart XL Defibrillator Recalled for Rotary Switch Failure

    Philips is recalling HeartStart XL Defibrillators because a faulty switch may prevent the device from turning on or delivering the correct shock energy.

    Product
    Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2018-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2012-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2023-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2013-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2024-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2021-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2027-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2020·2020-05-27

    ICU Medical Recalls Lactated Ringer's Injection Due to Iron Oxide Particulates

    ICU Medical Inc. is recalling 93,648 units of Lactated Ringer's Injection due to confirmed iron oxide particulate matter.

    Product
    LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2030-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Open Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2029-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2009-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2034-2020·2020-05-27

    Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2010-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 10888857108240, Size 24x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2022-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2008-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling 211 units of the Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2031-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage

    K2M, Inc. is recalling Aleutian Interbody Spacer Systems because the welded spreader tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0952-2020·2020-05-27

    Ricker Hill Orchards Apple Cider Recalled for High Patulin Levels

    Ricker Hill Orchards is recalling McIntosh Blend apple cider in Maine due to high levels of patulin.

    Product
    RICKER HILL ORCHARDS APPLE CIDER McIntosh Blend, 1 GAL (128 FL OZ) and 1/2 GAL (64 FL OZ); UPC: 0 74613 80009 8; MADE IN MAINE; KEEP REFRIGERATED; Produced by Ricker Hill Orchards, Turner, ME 04282
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2015-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2020·2020-05-27

    Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a risk of insufficient vessel occlusion during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V303000·2020-05-27

    Motorhome wire harness may damage fuel pump and brake systems

    Certain 2020-2021 Thor Motor Coach motorhomes may have a wire harness that contacts the frame, potentially damaging fuel pump and brake circuits and increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH AXIS, VEGAS, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2020·2020-05-27

    NelDerm Hydrogel Dressing Recalled for Foreign Material in Packaging

    Nelson Innovations is recalling NelDerm Hydrogel Dressings due to foreign material near the adhesive edge within the pouch packaging.

    Product
    NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2062-2020·2020-05-27

    Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling

    Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.

    Product
    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2020·2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson & Co. is recalling BD BBL Gram Crystal Violet stain because increased artifacts may cause false-positive Gram stain results.

    Product
    BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E033000·2020-05-27

    Horizon Recalls Tekonsha Prodigy Electronic Brake Control Kits

    Horizon Global is recalling certain Tekonsha Prodigy electronic brake control kits because they do not adequately warn drivers that foot pedal trailer braking is unavailable when hazard signals are active.

    Product
    ELECTRICAL SYSTEM: INTEGRATED TRAILER BRAKE CONTROL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2014-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2020·2020-05-27

    Cardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse

    Cardinal Health is recalling B-Hydroxybutyrate LiquiColor test kits because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure

    Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2020·2020-05-27

    BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

    Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

    Product
    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0949-2020·2020-05-27

    Wegmans Semi-Sweet Chocolate Nonpareils Recalled for Undeclared Milk Allergen

    Mellace Family Brands is recalling Wegmans brand Semi-Sweet Chocolate Nonpareils because the product may contain undeclared milk.

    Product
    Wegmans brand Semi-Sweet Chocolate Nonpareils in an 18.5 oz. (524 g) plastic container, 12 plastic containers per case.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1995-2020·2020-05-27

    Medtronic Nexframe Stereotactic System Recalled for Lead Placement Inaccuracies

    Medtronic is recalling the Nexframe Stereotactic System and specific software combinations due to potential inaccuracies in deep brain stimulation lead placement.

    Product
    Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2020·2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0970-2020·2020-05-27

    Willamette Valley Cherry Pie Recalled for Mislabeling as Raspberry Rhubarb

    Willamette Valley Pie Company is recalling Cherry Pies that are actually Raspberry Rhubarb Pies. The mislabeling creates a risk for consumers with almond allergies.

    Product
    Willamette Valley Pie Company Cherry Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87916 9. The label on a clamshell container is read in parts: "***HANDMADE All-Natural Cherry Pi
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2074-2020·2020-05-27

    Dako Autostainer Instruments Recalled for Potential False Negative Staining Results

    Dako is recalling 796 Autostainer instruments because a missing syringe tray may cause excess buffer application, potentially leading to false negative staining results.

    Product
    Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2020·2020-05-27

    Baylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect

    Baylis Medical is recalling NRG RF Transseptal Kits because sterile packaging may be compromised during shipping, posing a remote risk of infection.

    Product
    NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0948-2020·2020-05-27

    Condies Foods Recalls Chicken Sandwiches Due to Undeclared Soy Allergen

    Condies Foods, Inc. is recalling 61 chicken sandwiches distributed in Utah because they contain undeclared soy. The error occurred when the wrong ingredient was purchased and used.

    Product
    43559 SNDW Chicken Sandwich on White Single, vacuumed pack bag, Clam shell. Label UPC: 50777444804, Condies Foods Inc. PO Box 18548. Salt Lake City, UT
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2063-2020·2020-05-27

    Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure

    Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.

    Product
    Frames Direct Prescription Spectacle Lenses included in the frame brands
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2048-2020·2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2020·2020-05-27

    Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2020·2020-05-27

    Medline Recalls Surgical Kits Due to Potential Loss of Sterility

    Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.

    Product
    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2020·2020-05-27

    Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue

    The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.

    Product
    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighNHTSA·20E032000·2020-05-27

    Akron Brass Recalls Wireless Firefighting Monitor Remote Controllers

    Akron Brass is recalling 53 wireless remote controllers for electric firefighting monitors because a disabled sleep mode causes batteries to discharge faster than normal.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2020·2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test results.

    Product
    BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2020·2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2020·2020-05-27

    Medline Recalls Silicone Foley Catheters Due to Loose Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighNHTSA·20V308000·2020-05-27

    Thor Motor Coach Recalls 2020 Motorhomes Due to Manual Error

    Thor Motor Coach is recalling 566 2020 motorhomes because the owner's manual incorrectly describes the automatic parking function, which could lead to vehicle rollaway.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR SIESTA, SYNERGY, GEMINI, DELANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2020·2020-05-27

    Clinical Innovations Recalls Kiwi Vacuum Delivery System Due to Vacuum Failure

    Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System because the device may fail to generate or maintain vacuum during use.

    Product
    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0969-2020·2020-05-27

    Willamette Valley Pie Company Recalls Raspberry Rhubarb Pie Due to Undeclared Almond

    Willamette Valley Pie Company is recalling Raspberry Rhubarb Pie because the product is actually Cherry Pie containing undeclared artificial almond extract.

    Product
    Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87931 2. The label on a clamshell container is read in parts: "***HANDMADE All-Natural
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2095-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2026-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

    Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2066-2020·2020-05-27

    Baxter Recalls Prismaflex Control Units Lacking FDA Clearance

    Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.

    Product
    Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2069-2020·2020-05-27

    Baylis Medical Recalls TorFlex Transseptal Guiding Sheaths Due to Packaging Defects

    Baylis Medical is recalling TorFlex Transseptal Guiding Sheaths because sterile packaging may be compromised during shipping, posing a remote risk of infection.

    Product
    TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF8
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2097-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2086-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2073-2020·2020-05-27

    Capso Vision Recalls CapsoCam Plus Capsule Endoscopy Systems Due to Labeling Errors

    Capso Vision, Inc. is recalling 44 CapsoCam Plus video capsule systems because incorrect serial number labels may lead to patient misdiagnosis.

    Product
    CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2093-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may detach from its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2068-2020·2020-05-27

    Merit Medical Recalls DFINE Vertebral Assemblies Due to Incorrect Expiration Dates

    Merit Medical Systems is recalling 63 DFINE Vertebral Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2089-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2088-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-1282-2020·2020-05-27

    West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures

    West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.

    Product
    Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2020·2020-05-27

    Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags

    Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.

    Product
    HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0956-2020·2020-05-27

    Frito-Lay Recalls Ruffles Onion Dip Jars Due to Mold Contamination Risk

    Frito-Lay is recalling Ruffles Onion flavoured dip jars in the US and Canada due to potential mold contamination.

    Product
    Ruffles Onion flavoured dip 425 g (15 oz). UPC 6041007298 packaged in clear glass jars
    Category
    Food
    Distribution
    0 states

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