The Recall Desk

Archive

December 2020 recalls

500 recalls were announced in December 2020.

What the numbers show

Critical
15
Severe
129
High
252
Moderate
97
Low
7

Of the 500 recalls this month scored against our rubric, 3% are Critical, 26% are Severe.

Which agencies issued them

101–200 of 500

  • HighFDA (Devices)·Z-0644-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2021·2020-12-30

    ICU Medical Recalls Spiros Blood Sets Due to Molding Defect

    ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.

    Product
    26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2021·2020-12-30

    PryTime Medical Recalls ER-Reboa Plus Catheters Due to Marking Errors

    PryTime Medical is recalling 3 units of ER-Reoba Plus Catheters because they may have incorrect balloon and arterial line markings, which could delay procedures or injure patients.

    Product
    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2021·2020-12-30

    Haag-Streit Surgical Floor Stands Recalled for Software Error

    Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.

    Product
    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2021·2020-12-30

    ICU Medical Recalls Spiros and Clave IV Administration Sets

    ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.

    Product
    5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2021·2020-12-30

    Integra Recalls Mislabeled Bactiseal Endoscopic Ventricular Catheters

    Integra LifeSciences is recalling 17 Bactiseal Endoscopic Ventricular Catheters due to mislabeling. The devices were incorrectly identified as a different catheter model.

    Product
    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0677-2021·2020-12-30

    IceEDGE Cryoablation Needle gas leak recall issued by FDA

    Boston Scientific Corporation recalled 525 IceEDGE cryoablation needles due to reported gas leaks in the needle shaft, affecting nationwide distribution.

    Product
    IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2021·2020-12-30

    Biomet Vanguard 360 Knee Augment Recall Due to Incorrect Bolts

    Biomet is recalling 21 units of Vanguard 360 Revision System Posterior Augments because tibial bolts were packaged instead of femoral bolts, which may delay knee arthroplasty procedures.

    Product
    Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2021·2020-12-30

    Fresenius Kabi Recalls Sensorcaine Due to Low Epinephrine Levels

    Fresenius Kabi is recalling 4,411 trays of Sensorcaine (Bupivacaine HCl and Epinephrine) because the epinephrine component tested below specification.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2021·2020-12-30

    Integra Recalls Mislabeled Bactiseal Ventricular Catheters for Hydrocephalus Treatment

    Integra LifeSciences is recalling 85 units of Bactiseal Ventricular Catheters that were mislabeled as Endoscopic Ventricular Catheters. The error involves swapped product labels for part numbers 823073 and 823087.

    Product
    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0183-2021·2020-12-30

    Flowers Foods Recalls Canyon Bakehouse Gluten Mountain White Bread

    Flowers Foods is recalling Canyon Bakehouse Gluten Mountain White Bread because some products contained higher than acceptable levels of gluten.

    Product
    CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00200 3
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-0187-2021·2020-12-30

    Meijer Organic Green Peas Recalled for Potential Nightshade Contamination

    Meijer Distribution is recalling True Goodness Organic Green Peas because the product may contain nightshade.

    Product
    True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, 12 bags per case-pack
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0188-2021·2020-12-30

    Dole Recalls President's Choice Coleslaw Due to CCP Deviation

    Dole Fresh Vegetables Inc is recalling President's Choice Coleslaw due to a deviation in the wash process. The product was in transit in Canada and destroyed.

    Product
    Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0713-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0722-2021·2020-12-30

    Siemens Atellica GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.

    Product
    Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0182-2021·2020-12-30

    Canyon Bakehouse Gluten-Free Bagels Recalled for High Gluten Levels

    Flowers Foods is recalling Canyon Bakehouse Gluten-Free Bagels because some products contained higher than acceptable levels of gluten.

    Product
    CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0715-2021·2020-12-30

    Baxter Spectrum IQ Infusion System Recalled for Potential Software Error

    Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect

    GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2021·2020-12-30

    Biocomposites Recalls Stimulan Kit 10cc Due to Mislabeled Product

    Biocomposites, Ltd. is recalling 54 boxes of Stimulan Kit 10cc, Model 600-010, because the product is mislabeled. The recall affects units distributed in the US, Puerto Rico, and Costa Rica.

    Product
    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0698-2021·2020-12-30

    AMT ENFit-to-Stepped Male Adapter Recalled for Incorrect Pouch Labels

    Applied Medical Technology Inc is recalling specific lots of ENFit-to-Stepped Male adapters because the inner pouches may have incorrect labels, although the outer boxes are correct.

    Product
    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E094000·2020-12-28

    Summit Racing 6-Ton Jack Stands Recalled Due to Ratchet Bar Failure Risk

    Autosales Inc. is recalling Summit Racing 6-Ton Jack Stands because the ratchet bar may fail, allowing the vehicle to fall. Owners should stop using the stands and contact Autosales for a refund.

    Product
    EQUIPMENT:MECHANICAL:ACCESSORY SCISSOR/SCREW/BOTTLE JACK/LIFT:STAND recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V814000·2020-12-28

    Yamaha Motorcycles Recalled for Front Brake Switch Failure

    Yamaha is recalling motorcycles for a front brake switch defect that can keep the brake light on or cause unexpected cruise control shutoff, increasing crash risk. Contact Yamaha customer service at 1-800-962-7926 for a free replacement.

    Product
    YAMAHA — YAMAHA FJR1300, XTZ12, XV1900, MT-10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0172-2021·2020-12-23

    Holiday Cookie Platter Recalled for Undeclared Pecans

    George DeLallo Co. is recalling Holiday Cookie Platters due to undeclared pecans, a major food allergen.

    Product
    Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-0168-2021·2020-12-23

    AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up

    AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.

    Product
    TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2021·2020-12-23

    Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

    Taro Pharmaceuticals is recalling CVS Health Athlete's Foot Cream because an unknown degradation impurity was detected slightly above the specification limit.

    Product
    CLOTRIMAZOLE 1% — CLOTRIMAZOLE 1% (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0132-2021·2020-12-23

    FDA Recalls BPC-157 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling BPC-157 vials because production processes cannot assure the sterility of the product.

    Product
    BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0134-2021·2020-12-23

    Advanced Nutriceuticals Recalls IPAMORELIN Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling IPAMORELIN vials because production processes cannot assure the sterility of the product.

    Product
    IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0144-2021·2020-12-23

    Advanced Nutriceuticals Recalls Pentosan Polysulfate Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Pentosan Polysulfate vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereCPSC·21058·2020-12-23

    Urban Outfitters Recalls Taper Candle Holders Due to Fire Hazard

    Urban Outfitters is recalling Swirled and Sofia Taper Candle Holders because they can catch fire if they contact a flame. Consumers should stop using them and return them for a refund.

    Product
    Swirled Taper and Sofia Taper Candle Holders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0131-2021·2020-12-23

    FDA Recalls AOD-9604 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling AOD-9604 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0137-2021·2020-12-23

    Advanced Nutriceuticals Recalls B12 Injection Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling B12 for Injection vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0139-2021·2020-12-23

    FDA Recalls Cerebrolysin Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Cerebrolysin vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0140-2021·2020-12-23

    FDA Recalls Thymosin Beta-4 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Thymosin Beta-4 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0586-2021·2020-12-23

    DePuy Synthes 17.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0575-2021·2020-12-23

    DePuy Synthes 12.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHRP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHRP vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0143-2021·2020-12-23

    Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0573-2021·2020-12-23

    DePuy Synthes 11.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2021·2020-12-23

    FDA Recalls NANDROLONE Injections Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling NANDROLONE 200 mcg/mL injections because production processes cannot assure sterility. The recall affects vials distributed to seven states.

    Product
    NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0130-2021·2020-12-23

    PT-141 Injection Recalled Due to Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling PT-141 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0577-2021·2020-12-23

    DePuy Synthes 13.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0129-2021·2020-12-23

    Advanced Nutriceuticals Recalls FGL Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling FGL 10 mg/ml vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0149-2021·2020-12-23

    BASF Recalls Crospovidone Excipient Due to Theophylline Contamination

    BASF Corporation is recalling 4,560 kg of Kollidon CL-M Crospovidone excipient because it was found to be cross-contaminated with theophylline.

    Product
    Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0128-2021·2020-12-23

    FDA Recalls CJC-1295 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling CJC-1295 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0583-2021·2020-12-23

    DePuy Synthes 16.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2021·2020-12-23

    DePuy Synthes 18.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 18.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0574-2021·2020-12-23

    DePuy Synthes 11.5mm Reamer Head Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0580-2021·2020-12-23

    DePuy Synthes 14.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0572-2021·2020-12-23

    DePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0142-2021·2020-12-23

    High Dose B12 Injection Recalled for Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling High Dose B12 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0141-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHK-CU Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHK-CU vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0578-2021·2020-12-23

    DePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0581-2021·2020-12-23

    DePuy Synthes 15.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue or bone damage.

    Product
    DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0584-2021·2020-12-23

    DePuy Synthes 16.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads because breakage exceeds expected rates, causing tissue and bone damage.

    Product
    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0614-2021·2020-12-23

    Carl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling 132 VISUREF 150 diagnostic instruments due to an incorrect component that may cause electrical shocks to users.

    Product
    Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2021·2020-12-23

    Advanced Nutriceuticals Recalls DSIP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling DSIP vials because production processes cannot assure sterility. The product was distributed to specific states.

    Product
    DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0585-2021·2020-12-23

    DePuy Synthes 17.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2021·2020-12-23

    DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2021·2020-12-23

    Thymosin Alpha Vials Recalled for Sterility Assurance Concerns

    Advanced Nutriceuticals, LLC is recalling Thymosin Alpha vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0165-2021·2020-12-23

    Cipla Recalls Azacitidine Injection Vials Due to Sterility Concerns

    Cipla is recalling 2,151 vials of Azacitidine for Injection due to potential sterility issues caused by improper sealing.

    Product
    Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0576-2021·2020-12-23

    DePuy Synthes 12.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0579-2021·2020-12-23

    DePuy Synthes 14.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.0MM Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E093000·2020-12-23

    Autosales Recalls Summit Racing 3-Ton Jack Stands Due to Ratchet Bar Failure

    Autosales is recalling Summit Racing 3-Ton Jack Stands because the ratchet bar may fail, allowing a vehicle to fall. Owners should stop using the stands and contact Autosales for a refund.

    Product
    EQUIPMENT:MECHANICAL:ACCESSORY SCISSOR/SCREW/BOTTLE JACK/LIFT:STAND recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·21059·2020-12-23

    Hampton Bay Mara Ceiling Fans Recalled for Blade Detachment Hazard

    King of Fans is recalling Hampton Bay 54-inch Mara ceiling fans because blades can detach while in use, posing an injury hazard.

    Product
    Hampton Bay 54-inch Mara Indoor/Outdoor Ceiling Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·031-2020·2020-12-23

    CLS Gourmet Recalls Meat Products Produced Without Federal Inspection

    CLS Gourmet CL Saigon Food Company is recalling approximately 128,841 pounds of raw and cooked meat products produced without federal inspection.

    Product
    CLS Gourmet CL Saigon Food Company Recalls Meat Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.

    Product
    4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2021·2020-12-23

    Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error

    Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.

    Product
    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21057·2020-12-23

    GSK Recalls Five Excedrin Brands Due to Child-Resistant Packaging Defects

    GSK Consumer Healthcare is recalling five Excedrin brands because some bottles have holes in the bottom, posing a risk of poisoning to children.

    Product
    Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2021·2020-12-23

    Mizuho Microsurgical Operating Room Tables Recalled for Unintended Movement

    Mizuho America is recalling 10 microsurgical operating room tables due to unintended tilting and infrared signal errors that may cause incorrect operation.

    Product
    Microsurgical Operating Room Tables;7300BX (18-351-70).
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2021·2020-12-23

    Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.

    Product
    RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Const
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2021·2020-12-23

    Biomet Reverse Shoulder System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of the Comprehensive Reverse Shoulder System because a breach in the sterile seal could lead to loss of sterility.

    Product
    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2021·2020-12-23

    Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates

    Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.

    Product
    Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2021·2020-12-23

    Biomet Recalls Cannulated Screw Systems Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2021·2020-12-23

    RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

    RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

    Product
    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2021·2020-12-23

    CitruGel Hand Sanitizer Recalled for Subpotent Drug Content

    Simex Logistics SA de CV is voluntarily recalling 1,800 bottles of CitruGel Hand Sanitizer because the product is subpotent.

    Product
    CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0625-2021·2020-12-23

    Biomet Phoenix Interlocking Screws Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Phoenix interlocking screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0624-2021·2020-12-23

    Biomet Oxford Fixed Lateral Knee Implants Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.

    Product
    Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2021·2020-12-23

    Biomet RingLoc+ Drill Bits Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.

    Product
    RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2021·2020-12-23

    Biomet Recalls Titanium IFS Devices Due to Potential Sterile Seal Breach

    Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.

    Product
    Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2021·2020-12-23

    Enterix Recalls InSure ONE Test Strips Due to Potential False Positives

    Enterix, Inc. is recalling InSure ONE Test Strips because they may produce false positive results, potentially leading to unnecessary medical procedures.

    Product
    InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2021·2020-12-23

    Biomet Ringloc Acetabular System Screws Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Met
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2021·2020-12-23

    Biomet RapidFire Clip Recall Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation because a breach in the sterile seal could lead to loss of sterility.

    Product
    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2021·2020-12-23

    Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.

    Product
    Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2021·2020-12-23

    Ra Medical Systems Recalls DABRA Laser Due to Footswitch Defect

    Ra Medical Systems is recalling 36 DABRA Laser devices because the footswitch may fail to protect against liquid ingress, potentially causing the laser to remain on.

    Product
    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0620-2021·2020-12-23

    Biomet Shoulder System Surgical Handles Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.

    Product
    Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V810000·2020-12-23

    International DuraStar and WorkStar Engine Control Software Defect Recall

    Navistar recalls 17,213 2014-2021 International commercial trucks with an engine control defect. The software flaw can cause unexpected vehicle movement when parked with the PTO engaged, risking crashes and injury.

    Product
    INTERNATIONAL — INTERNATIONAL MV, DURASTAR, WORKSTAR, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0189-2021·2020-12-23

    Treehouse Foods Recalls Honey Mustard Dressing for Unlabeled Milk

    Treehouse Foods is recalling House Recipe Honey Mustard Dressing & Dip because it contains milk, which is not listed on the label.

    Product
    HOUSE RECIPE HONEY MUSTARD DRESSING & DIP NET WT 1 OZ.(28g) cup CONTAINS: EGGS DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077 UPC 0 73473 05797 8
    Category
    Food
    Distribution
    1 state

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