The Recall Desk

Archive

January 2021 recalls

307 recalls were announced in January 2021.

What the numbers show

Critical
9
Severe
102
High
139
Moderate
44
Low
13

Of the 307 recalls this month scored against our rubric, 3% are Critical, 33% are Severe.

Which agencies issued them

201–300 of 307

  • SevereFDA (Drugs)·D-0215-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 428 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0194-2021·2021-01-13

    Bonduelle Frozen Carrot Cubes Recalled for Metal Fragments

    Bonduelle Canada Inc. is recalling specific lots of frozen carrot cubes and diced carrots due to the potential presence of metal fragments.

    Product
    HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos 3/8" 1/25LB - bag in box product in corrugated case; Classic Carot Cubes 12/2LB/Classic DCD Carrots 12/2LB - corrugated cases of 12 individual
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0187-2021·2021-01-13

    SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.

    Product
    Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0210-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0203-2021·2021-01-13

    SCA Pharmaceuticals Recalls Neostigmine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 390 syringes of neostigmine methylsulfate due to a lack of assurance of sterility and potential defective caps.

    Product
    neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2021·2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2021·2021-01-13

    Accuray TomoTherapy System Recalled for MLC Tickling Error

    Accuray is recalling seven TomoTherapy Treatment Systems because an MLC tickling error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2021·2021-01-13

    DePuy Pinnacle Hip Cups Recalled for Potential Cross-Threaded Apex HE Fixation

    DePuy Orthopaedics is recalling Pinnacle Hip Cups because the Apex HE screw may thread through the cup shell without stopping, potentially protruding internally.

    Product
    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21068·2021-01-13

    Sea to Summit Recalls Camping Pots Due to Burn and Scald Hazards

    Sea to Summit is recalling Alpha and Sigma camping pots because the nylon latch can disengage, causing the handle to detach and posing burn and scald hazards.

    Product
    Sea to Summit Alpha and Sigma camping pots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2021·2021-01-13

    Medline Thyroid Pack Recall Due to Non-X-Ray Detectable Sponge

    Medline Industries is recalling 40 Thyroid Pack CKHA-LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only to Canada.

    Product
    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0768-2021·2021-01-13

    Baxter MiniCap Extended Life PD Transfer Set Recalled for Leak Risk

    Baxter Healthcare is recalling 72,771 units of MiniCap Extended Life PD Transfer Sets due to a potential for no-flow and leaks under the twist clamp.

    Product
    MiniCap Extended Life PD Transfer Set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21066·2021-01-13

    Belkin Recalls Portable Wireless Chargers Due to Fire and Shock Hazards

    Belkin is recalling about 2,280 Portable Wireless Charger + Stand Special Edition units because a manufacturing defect can cause overheating, posing fire and shock risks.

    Product
    Belkin "Portable Wireless Charger + Stand Special Edition"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0199-2021·2021-01-13

    Backroad Country Spicy Cajun Mix is recalled due to undeclared milk allergens.

    The FDA is recalling Backroad Country Spicy Cajun Mix because it contains undeclared milk allergens. Consumers should not consume this product until further notice.

    Product
    Backroad Country Spicy Cajun Mix 9 oz (255g) plastic bag. Packed by Troyer Manufacturing Millersburg, OH 44654.
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0782-2021·2021-01-13

    Medline Aortic Graft Kits Recalled for Non-Detectable Sponge Component

    Medline Industries is recalling 45 aortic graft kits in Canada because the included sponge is not x-ray detectable.

    Product
    Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0193-2021·2021-01-13

    Rich Products Cake Truffles Recalled for Undeclared Wheat

    Rich Products Corp is recalling 589 cases of Cake Truffles because the product contains undeclared wheat.

    Product
    OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt. 19.5 oz(1 LB 3.5 oz) (552 g)
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0804-2021·2021-01-13

    Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.

    Product
    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2021·2021-01-13

    Medline Cardiac Pack Recall for Non-X-Ray Detectable Sponge Component

    Medline Industries is recalling Cardiac Pack - LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only in Canada.

    Product
    Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0801-2021·2021-01-13

    Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

    Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect patient results.

    Product
    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0197-2021·2021-01-13

    Valanga Gourmet Snickerdoodle Cookies Recalled for Undeclared Milk Allergen

    Avalanche Distributing is recalling 1,700 Valanga Gourmet Snickerdoodle Cookies because the label fails to declare milk, a major allergen, despite containing whey.

    Product
    Valanga Gourmet brand Snickerdoodle Cookie with cinnamon sugar on the outside. Each cookie is wrapped and sold individually. Expected shelf life 6 months frozen and 2 months refrigerated. Net wt. 4.4 oz (124g). UPC 814524616004. The Snickerdoodle Cookie label is read in par
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0803-2021·2021-01-13

    Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.

    Product
    CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2021·2021-01-13

    Linet Eleganza 5 Adjustable Bed Recalled for Side Rail Malfunction

    Linet Spol. S.r.o. is recalling 518 Eleganza 5 adjustable beds because a side rail component may malfunction, causing the rail to fail to lock or become stuck in the upper position.

    Product
    Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Fitting Detachment

    Boston Scientific is recalling Hot AXIOS Stent delivery systems because a fitting may detach, risking leakage of bodily contents into the peritoneal cavity.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2021·2021-01-13

    Medline Simple Neck Dissection Kit Recalled for Non-X-Ray Detectable Sponge

    Medline Industries is recalling 90 units of Simple Neck Dissection kits because the cylindrical sponge component is not x-ray detectable.

    Product
    Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0198-2021·2021-01-13

    Country Fresh Party Tray Vegetables Recalled for Undeclared Egg Allergen

    Country Fresh Orlando, LLC is recalling Party Tray Vegetables with Ranch Dip due to undeclared egg. The product was distributed in Florida.

    Product
    Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0774-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk

    Boston Scientific is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21067·2021-01-13

    Juratoys Recalls Janod Toy Trumpets Due to Choking Hazard

    Juratoys is recalling Janod Toy Confetti Trumpets because small plastic pieces can come loose and pose a choking hazard to children.

    Product
    Janod Toy Confetti Trumpets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2021·2021-01-13

    Medline Recalls Non-X-Ray Detectable Surgical Sponges in Convenience Kits

    Medline Industries is recalling 88 surgical convenience kits because the cylindrical sponge component is not x-ray detectable. The affected products were distributed only in Canada.

    Product
    Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0772-2021·2021-01-13

    Smith & Nephew Recalls Trigen Intertan Bone Fixation Nails for Packaging Error

    Smith & Nephew is recalling 41 units of Trigen Intertan bone fixation nails due to a manufacturing packaging error. The devices were distributed nationwide and in Australia, Canada, and the UK.

    Product
    Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2021·2021-01-13

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed after steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2021·2021-01-13

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the outside label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2021·2021-01-13

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0770-2021·2021-01-13

    Ortho VITROS CKMB Slides Recalled for Potential Falsely Elevated Results

    Ortho Clinical Diagnostics is recalling VITROS CKMB Slides because CK-MM interference may cause falsely elevated creatine kinase MB results.

    Product
    VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2021·2021-01-13

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside.

    Product
    Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0201-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 751 syringes of Morphine Sulfate 3 mg/3 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0795-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration Defect

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0797-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0791-2021·2021-01-13

    Steris Vis-U-All Heat Seal Pouches Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0789-2021·2021-01-13

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside the pouch.

    Product
    Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0794-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0799-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration on Exterior Labels

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects or ink transfer to devices.

    Product
    Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0787-2021·2021-01-13

    Steris Vis-U-All High Temperature Tubing Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0796-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0798-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V005000·2021-01-12

    Smeal Recalls 2020 Aerial and Pumper Vehicles for Remote Controller Defect

    Smeal is recalling 2020 Aerial and Pumper vehicles because a wireless remote controller defect may cause batteries to discharge faster, potentially hindering firefighting efforts.

    Product
    SMEAL — SMEAL AERIAL, PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E003000·2021-01-12

    Strategic Sports Recalls Simpson Shorty OTW Motorcycle Helmets

    Strategic Sports is recalling 3,752 Simpson Shorty OTW helmets that lack proper retention and protection, increasing crash injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V003000·2021-01-08

    Braun Recalls Crestline Ambulances Due to Defective Seat Belt Fasteners

    Braun Ambulances is recalling specific Crestline CCL150 ambulances because defective seat belt fasteners may fail, increasing injury risk in a crash.

    Product
    CRESTLINE COACH — CRESTLINE COACH CCL150 TYPE III, CCL150 TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V002000·2021-01-08

    Marion Body Works Recalls 2018 Freightliner M2 License Plate Light

    Marion Body Works is recalling one 2018 Freightliner M2-106 vehicle because a license plate light may be aimed at other drivers, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V001000·2021-01-07

    Volvo Recalls 2021 Models for SRS Control Unit Attachment Defect

    Volvo is recalling 2021 V60, V90, XC60, and XC90 models because the SRS control unit may detach during a crash, reducing occupant protection.

    Product
    VOLVO — VOLVO XC90, XC60, V60, V60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01072021-01·2021-01-07

    HyVee Chicken Enchiladas Recalled for Undeclared Soy Allergen

    USDA FSIS issued a public health alert for HyVee Chicken Enchiladas due to misbranding and an undeclared soy allergen. Consumers with soy allergies should discard the product.

    Product
    FSIS Issues Public Health Alert for Not-Ready-to-Eat, Heat Treated, Not Fully Cooked Chicken Enchilada Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • HighCPSC·21718·2021-01-07

    Noble House Recalls Chests and Cabinets Due to Tip-Over Hazards

    Noble House Home Furnishings is recalling four models of chests, cabinets, and dressers because they are unstable and can tip over, posing serious hazards to children.

    Product
    Chests, cabinets and dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21717·2021-01-07

    John Deere Recalls Frontier Rotary Tillers Due to Injury Hazard

    John Deere is recalling Frontier rotary tillers because some lack a safety sign warning of entanglement hazards. No injuries have been reported.

    Product
    Frontier model rotary tillers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0220-2021·2021-01-06

    WishGarden Herbs Recalls Goldenseal Powder Jars Due to Microbial Contamination

    WishGarden Herbs is recalling 298 jars of Goldenseal Powder because testing found Cronobacter Sakazakii contamination.

    Product
    Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0218-2021·2021-01-06

    Wishgarden Herbs Recalls Happy Ducts Compress Due to Microbial Contamination

    Wishgarden Herbs is recalling 46 jars of Happy Ducts Compress because the product tested positive for Cronobacter Sakazakii.

    Product
    Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2021·2021-01-06

    Cipla Recalls Esomeprazole Magnesium Packets Due to Cross-Contamination

    Cipla is recalling 284,610 packets of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2021·2021-01-06

    Cipla Recalls Esomeprazole Magnesium Suspension Due to Theophylline Contamination

    Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg due to cross-contamination with theophylline in the excipient Crospovidone.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0766-2021·2021-01-06

    BD Phoenix PMIC-110 Recalled for False SXT Resistance Results

    Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact antibiotic treatment.

    Product
    BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 449036:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0761-2021·2021-01-06

    BD Phoenix PMIC-107 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.

    Product
    BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0748-2021·2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Loading Units

    FDA is recalling specific lots of Covidien TA Auto Suture Vascular Loading Units due to a damaged internal component that may prevent adequate hemostasis.

    Product
    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0747-2021·2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components

    The FDA is recalling specific lots of Covidien TA Auto Suture Vascular Staplers because a damaged internal component may prevent adequate hemostasis or cause tissue damage.

    Product
    Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·21064·2021-01-06

    Massimo Percussion Massage Guns Recalled Due to Fire Hazard

    Massimo Motor Sports is recalling percussion massage guns sold at Costco because the lithium-ion battery can overheat and cause fires.

    Product
    Massage Guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0190-2021·2021-01-06

    Landert Multigrain Bread Recalled for Unapproved Pesticide in Sesame Seeds

    Landert LLC is recalling Multigrain Solene Figotte breads due to unapproved ethylene oxide pesticide in sesame seeds.

    Product
    Multigrain Solene Figotte, prebaked frozen breads with seeds, Item 29497, Net Weight 8.8 Lbs (4 Kg), Lot: 1234567, UPC code (01)03604380294973(10)1234567(15)191121(91)0309000001,
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0177-2021·2021-01-06

    Imprimis Recalls Dexamethasone-Moxifloxacin Injection Due to Sterility Concerns

    Imprimis NJOF, LLC is recalling 6,520 vials of Dexamethasone-Moxifloxacin PF Injection because 13 vials were found with faulty crimps, raising concerns about sterility.

    Product
    Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0201-2021·2021-01-06

    Trader Joe's lightly salted edamame bags containing Listeria monocytogenes are recalled

    One bag of frozen Trader Joe's lightly salted edamame tested positive for Listeria monocytogenes and has been recalled due to potential foodborne illness risk.

    Product
    Trader Joe's Lightly Salted Edamame: Fully Cooked Soybeans in Pod. Keep Frozen NET WT 16 oz. (1 lb.) 454 g UPC: 0051 0639 Ingredients: Edamame (soybeans), salt Heating: microwave (1200 watt); Microwave cook times may vary depending on oven wattage. Open and pour into
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0764-2021·2021-01-06

    BD Phoenix PMIC/ID-109 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC/ID-109 because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

    Product
    BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448609
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2021·2021-01-06

    BD Phoenix PMIC/ID-105 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

    Product
    BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448605 (Discontinued)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2021·2021-01-06

    Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors

    Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.

    Product
    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2021·2021-01-06

    Boston Scientific Recalls Contour VL Ureteral Stents Due to Nickel Debris

    Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.

    Product
    Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2021·2021-01-06

    Roche cobas c 503 Analyzer Recalled for Inaccurate Test Results

    Roche Diagnostics is recalling cobas c 503 analyzers and kits because residual reagent transfer can cause inaccurately low results for therapeutic drug monitoring tests.

    Product
    cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0760-2021·2021-01-06

    BD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

    Product
    BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2021·2021-01-06

    Merit Medical Systems Recalls Custom Angiography Kits with Sealing Defects

    Merit Medical Systems is recalling 90 custom angiography kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.

    Product
    Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringe
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0737-2021·2021-01-06

    ROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges

    ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.

    Product
    Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0751-2021·2021-01-06

    Merit Medical Systems Recalls Cardiac Catheterization Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.

    Product
    Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0743-2021·2021-01-06

    Westmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment

    Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2021·2021-01-06

    Boston Scientific Recalls Contour VL Ureteral Stent Sets Due to Nickel Debris

    Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.

    Product
    Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2021·2021-01-06

    Westmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment

    Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.

    Product
    Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2021·2021-01-06

    BD Phoenix PMIC/ID-108 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling the BD Phoenix PMIC/ID-108 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

    Product
    BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recall for Seal Defect

    Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.

    Product
    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2021·2021-01-06

    Intersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port

    Intersurgical Inc is recalling 200 Smoothbore breathing systems with exhalation port 22 mm because they were assembled with the incorrect port, which can cause gas leakage.

    Product
    Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhala
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0763-2021·2021-01-06

    BD Phoenix PMIC-108 Recalled for False SXT Resistance Results

    Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective antibiotic treatment.

    Product
    BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448418
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2021·2021-01-06

    Westmed Adult Oxygen Mask Recall Due to Potential Loose Fitment

    Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.

    Product
    REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2021·2021-01-06

    Merit Medical Systems Recalls Custom Embolization Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 42 custom embolization kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.

    Product
    Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0745-2021·2021-01-06

    Westmed Adult Elongated Oxygen Mask Recalled for Loose Fitment

    Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

    Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

    Product
    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2021·2021-01-06

    Westmed Elongated Oxygen Mask Recalled for Loose Tube Connection

    Westmed is recalling 3,000 units of the REF 3102-E Elongated Oxygen Mask because the tube connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2021·2021-01-06

    Roche cobas pro integrated solutions recalled for potential incorrect results

    Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.

    Product
    Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2021·2021-01-06

    Westmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment

    Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.

    Product
    REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21060·2021-01-06

    Rust-Oleum Recalls Aerosol Paint Due to Container Detachment Injury Hazard

    Rust-Oleum is recalling about 10,500 cans of Professional Bright Galvanizing Compound Spray because the bottom of the pressurized container can detach unexpectedly, posing an injury hazard.

    Product
    Rust-Oleum Professional Bright Galvanizing Compound Spray
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2021·2021-01-06

    Recall of Cord Care Powder Due to Cronobacter Sakazakii Contamination

    A non-sterile Cord Care Powder product was recalled because testing found Cronobacter Sakazakii contamination, posing a potential health risk without confirmed illness reports.

    Product
    Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

    Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

    Product
    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0191-2021·2021-01-06

    Darlington's Soft Baked Cookies Recalled for Undeclared Milk

    HS Baking Enterprises is recalling specific lots of Darlington's Soft Baked Cookies because an ingredient contained a milk derivative that was not declared on the label.

    Product
    Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0183-2021·2021-01-06

    Cipla Recalls Esomeprazole Magnesium Due to Theophylline Contamination

    Cipla is recalling specific lots of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2021·2021-01-06

    BD Phoenix PMIC-109 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC-109 in vitro diagnostic devices because they may produce false resistant results for S. aureus, potentially affecting antibiotic treatment choices.

    Product
    BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448419
    Category
    Medical Device
    Distribution
    Distributed nationwide

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