The Recall Desk

Archive

September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical
56
Severe
123
High
285
Moderate
154
Low
13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 19% are Severe.

1–100 of 631

  • CriticalFDA (Drugs)·D-1595-2020·2020-09-30

    Protein Shoppe Recalls Red-E Tablets Tainted With Sildenafil

    The Protein Shoppe is recalling Red-E Tablets found to contain sildenafil, an unapproved drug for erectile dysfunction. The product was marketed without FDA approval.

    Product
    Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1530-2020·2020-09-30

    Frito-Lay 50 Count Flavor Mix Tray Recalled for Undeclared Milk

    Frito-Lay is recalling 50 count Flavor Mix trays due to potential undeclared milk. Consumers should stop eating the product and return it to the store.

    Product
    Frito-Lay 50 count Flavor Mix tray UPC 28400 05804 1 oz. individual bags packaged in a larger non-flexible tray
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-1587-2020·2020-09-30

    Gelbac T Hand Gel Recalled for Methanol Contamination

    Incredible Products is recalling Gelbac T Antibacterial Hand Gel because it contains methanol and is sub-potent for ethanol.

    Product
    Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 750227800
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-1528-2020·2020-09-30

    Frito-Lay Recalls Lays Sacks for Undeclared Milk

    Frito-Lay is recalling 10-count Lays sacks in 11 states due to a potential undeclared milk allergen.

    Product
    Frito-Lay 10 count Lays sack UPC 28400 31299 1 oz. individual bags packaged in a larger flexible bag
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1532-2020·2020-09-30

    Frito-Lay Classic Variety Mix Recalled for Undeclared Milk

    Frito-Lay is recalling 1,236 bags of Classic Variety Mix and Classic Mix due to potential undeclared milk. The products were distributed to retail and foodservice channels in 11 western states.

    Product
    Frito-Lay 30 count Classic Variety Mix tray Carton UPC 000 28400 52347 9, 1 1/2 oz. individual bags packaged in a larger tray AND Frito-Lay 30 count Classic Mix cube box UPC 28400 06241, 1 oz. individual bags packaged in a larger box
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-3005-2020·2020-09-30

    Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error

    Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.

    Product
    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2941-2020·2020-09-30

    MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports

    MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.

    Product
    PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1586-2020·2020-09-30

    Leafree Hand Sanitizer Recalled for Lacking FDA Approval

    Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.

    Product
    Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, Mc
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0006-2021·2020-09-30

    Toufayan Bakery Recalls Gluten-Free Animal Crackers Due to Undeclared Wheat

    Toufayan Bakery, Inc. is recalling Goodie Girl Gluten Free Magical Animal Crackers because the product was mixed with wheat-containing product, resulting in undeclared wheat.

    Product
    Goodie Girl, Gluten Free Magical Animal Crackers, 7 ounce , paper cartons, 6 packages per case, Best By JAN 11 21 A3
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1529-2020·2020-09-30

    Frito-Lay Classic Cube Mix Recalled for Undeclared Milk

    Frito-Lay is recalling 28-count Classic Cube Mix boxes because they may contain undeclared milk. The product was distributed to retail and foodservice channels in 11 western states.

    Product
    Frito-Lay 28 count Classic Cube Mix cube box UPC 28400 15586 1 oz. individual bags packaged in a larger non-flexible box
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1544-2020·2020-09-30

    Gilster-Mary Lee Recalls Organic Microwave Popcorn Due to Glass Contamination

    Gilster-Mary Lee Corp. is recalling specific brands of organic microwave popcorn because tempered glass pieces were found in the product.

    Product
    Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 oz (247 g), Distributed by Topco Associates LLC, Elk Grove Villiage, IL, UPC 36800-40611 2) Sprouts Farmers Market, Organic Salted Microwave
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-1623-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·20193·2020-09-30

    STIHL Recalls Mini-Cultivator Attachments Due to Laceration Hazard

    STIHL is recalling about 185,000 mini-cultivator attachments because the gearbox may be installed upside down, causing tines to rotate toward the operator and posing a laceration risk.

    Product
    STIHL BF-KM Mini-Cultivator attachments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1527-2020·2020-09-30

    Lay's Barbecue Potato Chips Recalled for Undeclared Milk

    Frito-Lay is recalling specific bags of Lay's Barbecue Flavored Potato Chips because they may contain undeclared milk.

    Product
    Lay's Barbecue Flavored Potato Chips 1 oz. UPC 28400 00861; Lay's Barbecue Flavored Potato Chips 1 1/2 oz. UPC 28400 00300; Lay's Barbecue Flavored Potato Chips 2 5/8 oz. UPC 28400 32420; Lay's Barbecue Flavored Potato Chips 7 3/4 oz. UPC 28400 19961; Lay's Barbecue Flavored
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1593-2020·2020-09-30

    Zanilast+ Gel Antiseptic Hand Sanitizer Recalled for Potential 1-Propanol Contamination

    Nanomateriales S.A. de C.V. is recalling 1,000 kg of Zanilast+ Gel Antiseptic Hand Sanitizer due to GMP deviations that may result in the presence of 1-propanol.

    Product
    Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·20V599000·2020-09-30

    Ford Recalls 2020 F-350 Trucks Due to Rear Axle Mismatch

    Ford is recalling 2020 F-350 trucks with ambulance prep packages because incorrect rear axles were installed, creating a risk of tire blowouts.

    Product
    FORD — FORD redundant F-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3000-2020·2020-09-30

    ArthroCare Recalls SmartStitch Connectors Due to Manufacturing Error

    ArthroCare Corporation is voluntarily recalling 15,559 units of Smith&Nephew SmartStitch PerfectPasser Connectors because a manufacturing error may cause the upper jaw to detach during use.

    Product
    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2989-2020·2020-09-30

    Wright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues

    Wright Medical Technology is recalling 16 Evolve Stem 8.5mm implants because they lack sterility assurance. The recall covers units distributed in the US and several international countries.

    Product
    EVOLVE STEM 8.5MM Model # 496S085
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1545-2020·2020-09-30

    Cadia Organic Unsalted Microwave Popcorn Recalled for Foreign Matter

    Gilster-Mary Lee Corp. is recalling Cadia Organic Unsalted Microwave Popcorn due to the presence of tempered glass fragments.

    Product
    Cadia Organic Unsalted Microwave Popcorn, Net Wt. 8.4 oz (238 g) 3-2.8 oz (79 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01289
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-2987-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling specific lots of Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1537-2020·2020-09-30

    Freshouse Produce Recalls Wegmans Valencia Oranges Due to Listeria Risk

    Freshouse Produce is recalling Wegmans Valencia Oranges after environmental sampling tested positive for Listeria monocytogenes. The product was distributed to wholesalers in Maryland and retailers in North Carolina, Pennsylvania, South Carolina, and Virginia.

    Product
    Wegmans Valencia Oranges, 4lb mesh bag, UPC 77890 52363
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1531-2020·2020-09-30

    Frito-Lay 18 Count Flavor Mix Sacks Recalled for Undeclared Milk

    Frito-Lay is recalling 18 count Flavor Mix sacks because they may contain undeclared milk. The product was distributed to retail and foodservice locations in 11 western states.

    Product
    Frito-Lay 18 count Flavor Mix sack UPC 28400 15443 1 oz. individual bags packaged in a larger flexible bag
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1540-2020·2020-09-30

    Trader Joe's Sweet Potato Bowl Recalled for Undeclared Allergens

    Renaissance Food Group is recalling Trader Joe's Southwest Style Sweet Potato Sauté Bowls because they may contain undeclared eggs and milk.

    Product
    Trader Joe's Southwest Style Sweet Potato Saut¿ Bowl NET WT. 21.05oz (1 LB 5.5 OZ) 610g UPC 00661126 packaged in a clear plastic bowl with lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1536-2020·2020-09-30

    Freshouse and Nature Promise Limes Recalled for Listeria Risk

    Freshouse Produce is recalling Freshouse and Nature Promise limes after environmental sampling tested positive for Listeria monocytogenes.

    Product
    Freshouse Limes, 2lb mesh bag, UPC 33383 14683 & Nature Promise Organic Limes, 1lb mesh bag, UPC 88267 53813
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-3013-2020·2020-09-30

    Medline Recalls Central Line Dressing Change Trays Due to Seal Defects

    Medline Industries is recalling Central Line Dressing Change Trays because incomplete seals may compromise sterility. The recall affects kits distributed in Minnesota and Texas.

    Product
    Central Line Dressing Change Tray
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2995-2020·2020-09-30

    GE Healthcare Recalls NM 830 Medical Detectors Due to Loose Screws

    GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.

    Product
    NM 830 Model # H3910AC
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-3012-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2990-2020·2020-09-30

    Hologic Recalls Panther Fusion Tube Trays Due to Potential Leaks

    Hologic is recalling 607 Panther Fusion Tube Trays because they may leak, potentially invalidating patient results or causing false negatives in flu and RSV assays.

    Product
    Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Food)·F-1541-2020·2020-09-30

    Gilster-Mary Lee Recalls Microwave Popcorn Due to Glass Contamination

    Gilster-Mary Lee Corp. is recalling Cadia and Lidl microwave popcorn because tempered glass fragments were found in the product.

    Product
    Lightly salted microwave popcorn packaged in the following ways: 1) Cadia Organic Lightly Salted Popcorn, Net Wt. 9.9 oz (281 g) 3-3.3 oz (94 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01288 2) Lidl, Naturally Flavored Butter Microwave Popcorn, 3-3.3 oz (94g) b
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-2984-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, all
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1535-2020·2020-09-30

    Freshouse Produce Recalls Lemons Due to Listeria Monocytogenes

    Freshouse Produce is recalling 2 lb mesh bags of lemons sold as Fresh from the Start and Wegmans brands due to positive environmental sampling for Listeria monocytogenes.

    Product
    Lemons, 2lb mesh bag sold under the brand names of Fresh from the Start, UPC 33383 14020 & Wegmans, UPC 77890 15917
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·20V601000·2020-09-30

    BMW recalls vehicles due to debris in hybrid battery cells

    BMW is recalling certain 2020-2021 models due to debris in hybrid battery cells that could cause fire or injury. Owners are instructed not to charge vehicles or drive in manual mode.

    Product
    BMW — BMW, MINI 745LE, X5, 530E, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V598000·2020-09-30

    BMW 2020-2021 Rearview Camera Software Obscures Rear View Image

    BMW is recalling approximately 312 certain 2020-2021 BMW models due to rearview camera software that may slightly obscure the rear view image, potentially increasing crash risk if drivers rely solely on the camera.

    Product
    BMW — BMW 530I, X3, X4, M550I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 94 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V600000·2020-09-30

    2021 Entegra motorhomes recalled for power seat wiring fire risk

    Jayco is recalling 2021 Entegra motorhomes with Villa power seats because the electrical wiring may become damaged or chafed, causing short circuits and fire risk.

    Product
    ENTEGRA — ENTEGRA REATTA XL, ASPIRE, CORNERSTONE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1542-2020·2020-09-30

    Gilster-Mary Lee Recalls Light Microwave Popcorn Due to Foreign Matter

    Gilster-Mary Lee Corp. is recalling specific lots of Full Circle and Nature's Promise light microwave popcorn because tempered glass pieces were found in the product.

    Product
    Light microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Light Butter, 3-2.9 oz (82 g) bags, Net Wt. 8.7 oz (247 g), Distributed by Topco Associates LLC, Elk Grove Villiage, IL, UPC 36800-40610 2) Nature's Promise, Microwave Popcorn B
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-1538-2020·2020-09-30

    Fresh from the Start Red B Potatoes Recalled for Listeria

    Freshouse Produce is recalling 8,262 bags of Fresh from the Start Red B Potatoes due to positive environmental sampling for Listeria monocytogenes.

    Product
    Fresh from the Start Red B Potatoes, 3lb mesh bag, UPC 33383 51003
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-1620-2020·2020-09-30

    AJR Trading Recalls Bio AAA Alcohol Gel Due to Methanol Presence

    AJR Trading LLC is recalling 2,000 bottles of Bio AAA Alcohol Gel because methanol was found in other lots from the same facility.

    Product
    bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2986-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2999-2020·2020-09-30

    ArthroCare Speed Stitch Needle Cassettes Recalled for Potential Breakage

    ArthroCare is recalling Speed Stitch Needle Cassettes because a supplier error may have resulted in needles made of titanium instead of stainless steel, posing a risk of breakage during use.

    Product
    Speed Stitch Needle Cassette
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2988-2020·2020-09-30

    LivaNova Recalls Perceval Dual Collapser Due to Valve Collapse Failure

    LivaNova is recalling specific lots of the Perceval Dual Collapser because complaints indicate the device may fail to collapse the heart valve during implantation.

    Product
    Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1543-2020·2020-09-30

    Gilster-Mary Lee Recalls Buttered Microwave Popcorn Due to Glass Fragments

    Gilster-Mary Lee Corp. is recalling specific brands of buttered microwave popcorn because tempered glass fragments were found in the product.

    Product
    Buttered microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Butter, 3-3.3 oz (94 g) bags, Net Wt. 9.9 oz (281 g), Distributed by Topco Associates LLC, Elk Grove Villiage, IL, UPC 36800-40609 2) Sprouts Farmers Market, Organic Butter M
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-1533-2020·2020-09-30

    Frito-Lay Classic Mix Recalled for Undeclared Milk

    Frito-Lay is recalling 54-count Classic Mix cube boxes because they may contain undeclared milk. The product was distributed to retail and foodservice channels in 11 states.

    Product
    Frito-Lay 54 count Classic Mix cube box UPC 28400 30817, 1 oz. individual bags packaged in a larger box
    Category
    Food
    Distribution
    11 states
  • HighCPSC·20194·2020-09-30

    Petzl Recalls Low-Stretch Kernmantle Ropes Due to Fall and Injury Hazard

    Petzl is recalling approximately 14,850 low-stretch kernmantle ropes sold in the U.S. and Canada because deep cuts or tape securing rope ends can cause failure, posing fall and injury hazards.

    Product
    Low-Stretch Kernmantle Ropes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1590-2020·2020-09-30

    Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas

    Grupo Yacana Mexico is voluntarily recalling 55,560 bottles of Yacana Alcohol Antiseptic 70% Topical Solution distributed in Texas due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1591-2020·2020-09-30

    Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas

    Grupo Yacana Mexico is voluntarily recalling 43,728 bottles of Yacana Alcohol Antiseptic 70% Topical Solution distributed in Texas due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1622-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2997-2020·2020-09-30

    GE Healthcare Recalls Discovery NM670 Pro Due to Loose Screws

    GE Healthcare is recalling nine Discovery NM670 Pro units because rotor bearing screws were found loose on the detector.

    Product
    Discovery NM670 Pro Model # H3100XB
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1592-2020·2020-09-30

    Zanilast+ Hand Sanitizer Recalled for Potential 1-Propanol Contamination

    Nanomateriales S.A. de C.V. is recalling Zanilast+ Gel Antiseptic Hand Sanitizer due to GMP deviations that may result in the presence of 1-propanol.

    Product
    Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Ca
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3006-2020·2020-09-30

    Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference

    Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.

    Product
    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2982-2020·2020-09-30

    Bio-Rad Recalls BioPlex 2200 Syphilis Assay Due to Increased Reactivity

    Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.

    Product
    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-trepo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1539-2020·2020-09-30

    Cedar's Cucumber Garlic Dill Tzatziki Recalled for Undeclared Ingredients

    Cedar's Mediterranean Foods is recalling 3,426 units of Cucumber Garlic Dill Tzatziki because the product contains undeclared Food Starch, Gelatin, and Natamycin.

    Product
    Cedar's Cucumber Garlic Dill Tzatziki, 12 oz packaged in clear plastic tubs; Made with GREEK YOGURT; INGREDIENTS: CULTURED PASTEURIZED NONFAT MILK, CULTURED PASTEURIZED CREAM, MILK PROTEIN CONCENTRATE, STABILIZER (TAPIOCA STARCH, AGAR-AGAR, PECTIN), CUCUMBER, GARLIC, SEA SALT, OR
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1624-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to Manufacturing Deviations

    Preferred Pharmaceuticals is voluntarily recalling Nature-Throid tablets due to CGMP deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1621-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2983-2020·2020-09-30

    Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

    Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

    Product
    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents samp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3011-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 15 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and batch numbers.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3003-2020·2020-09-30

    OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes

    OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.

    Product
    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3002-2020·2020-09-30

    OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes

    OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.

    Product
    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3001-2020·2020-09-30

    OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing

    OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.

    Product
    CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3004-2020·2020-09-30

    DNA Genotek PrepIT Q2A Kit Recalled for Expired Reagents

    DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.

    Product
    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V595000·2020-09-29

    Mercedes-Benz and Freightliner Sprinter Fuel Line Clamp Recall

    Daimler Vans USA is recalling 2019-2020 Sprinter vans because fuel line clamps may loosen, causing a fuel leak that increases fire risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500, SPRINTER 4500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V594000·2020-09-29

    2021 Newmar Motorhomes Recalled for Leveling Jack Fastening Defect

    Newmar is recalling certain 2021 motorhome models because the front leveling jacks may not be properly fastened to the chassis. If the jacks fail, the motorhome could unexpectedly drop, creating an injury risk.

    Product
    NEWMAR — NEWMAR ESSEX, DUTCH STAR, MOUNTAIN AIRE, LONDON AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E072000·2020-09-29

    Spartan Fire Recalls Gladiator and MetroStar Vehicles Due to Gauge Defect

    Spartan Fire is recalling 2018-2019 Gladiator and MetroStar vehicles because replacement gauges may prevent the Advanced Protection System from engaging, increasing injury risk in crashes.

    Product
    SPARTAN — SPARTAN, SPARTAN FIRE METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V592000·2020-09-28

    Shyft Recalls 2015-2019 Utilimaster Ram ProMaster Fleet Vehicles

    Shyft Group is recalling 2015-2019 Utilimaster Ram ProMaster fleet vehicles because the transmission shifter cable may disconnect, causing unintended vehicle movement.

    Product
    UTILIMASTER — UTILIMASTER RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V593000·2020-09-28

    Kenworth T680 Trucks Recalled for Brake System Valve Defect

    PACCAR is recalling 2016-2021 Kenworth T680 trucks because a brake valve defect may increase stopping distance and crash risk.

    Product
    KENWORTH — KENWORTH T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V589000·2020-09-25

    2021 Forest River Wildwood RV Cooktop May Pose Fire Risk

    Forest River is recalling 2021 Wildwood and Salem trailers. The cooktop flame may invert due to furnace air leakage, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V591000·2020-09-25

    2020-2021 Dynamax Isata Motorhomes Recalled for Engine Software Fire Risk

    Forest River is recalling 2020-2021 Dynamax Isata motorhomes due to engine software that fails to provide adequate warmup protection. The defect can cause bearing damage and engine block failure, risking oil leaks and fires.

    Product
    DYNAMAX — DYNAMAX ISATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V580000·2020-09-24

    Chrysler Recalls Jeep and Ram Vehicles for Front Seat Belt Retractor Defect

    Chrysler is recalling specific 2019-2020 Jeep and Ram vehicles because front seat belt retractors may not properly slow occupants in a crash, increasing injury risk.

    Product
    JEEP — JEEP, RAM GLADIATOR, 2500, WRANGLER, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V587000·2020-09-24

    Altec Recalls 2019-2020 Aerial Devices and Digger Derricks for Bolt Failure

    Altec is recalling 280 units of 2019-2020 aerial devices and digger derricks because bolts securing the pedestal to the turntable may fail, posing a risk of injury or death.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E071000·2020-09-24

    Dometic Recalls 3-Burner Cooking Stoves Due to Gas Leak Risk

    Dometic is recalling specific 3-burner cooking stoves because a saddle valve bolt may be overtightened, damaging the seal and causing a gas leak that increases fire risk.

    Product
    EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V588000·2020-09-24

    2020 Cadillac CT5 Electronic Brake Boost System Defect

    General Motors is recalling the 2020 Cadillac CT5 due to sensor contamination in the electronic brake boost system, which may reduce braking effectiveness and increase crash risk. GM will replace the module at no cost.

    Product
    CADILLAC — CADILLAC, CHEVROLET, BUICK XT4, CT4, CORVETTE, CT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20782·2020-09-24

    Vthrive Bioactive Multivitamins Recalled for Non-Child-Resistant Packaging

    The Vitamin Shoppe is recalling Vthrive Bioactive Women's One-Daily Multi vitamins because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    Vthrive Bioactive Women's One-Daily Multi vitamins
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V585000·2020-09-24

    2020-2021 Land Rover Range Rover Sport TPMS Software Malfunction Recall

    2020-2021 Land Rover Range Rover Sport vehicles have incorrect TPMS pressure settings that prevent the warning light from activating when tire pressure drops dangerously low. Owners should contact Land Rover to schedule a free software update.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·20V586000·2020-09-24

    Incorrect Tire Pressure Labels on 2020-2021 Land Rover Range Rover Sport

    Certain 2020-2021 Land Rover Range Rover Sport vehicles with 19-inch wheels have incorrect tire pressure information on their labeling. This could lead to improper tire inflation and loss of vehicle control.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·20V584000·2020-09-24

    2021 International MV and HV trucks missing required reflective tape

    Navistar is recalling 2021 International MV and HV trucks that may lack reflective tape on the cab, required by federal safety standards. Without it, trucks are less visible at night, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1513-2020·2020-09-23

    Wegmans Mini Peach Shortcake Recalled for Salmonella Risk

    Wegmans is recalling Mini Peach Shortcakes because raw peaches may be contaminated with Salmonella Enteritidis.

    Product
    Wegmans Mini Peach Shortcake; 5 oz; UPC 7789051240
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Drugs)·D-1584-2020·2020-09-23

    Maison Terre Goldenseal Root Powder Recalled for Microbial Contamination

    Maison Terre, LLC is recalling Goldenseal Root Powder Organic due to FDA findings of contamination with various microorganisms, including Cronobacter sakazakii.

    Product
    Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1619-2020·2020-09-23

    RLC Labs Recalls Subpotent Nature Throid Thyroid Medication

    RLC Labs Inc. is recalling Nature Throid 1.5 Grain thyroid medication because FDA analysis found the product to be subpotent.

    Product
    Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), R
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1438-2020·2020-09-23

    Wawona Fresh Peaches Recalled Due to Salmonella Enteritidis Outbreak Link

    Wawona Packing Co LLC is recalling fresh peaches because trace-back information links them to a Salmonella Enteritidis outbreak.

    Product
    Fresh peaches - sold loose/bulk and Bagged fresh peaches, 2 lbs. plastic pouch under brand names of: Wawona- UPC 033383322001 Wawona Organic- UPC 849315000400 Prima - UPC 766342325903, Walmart Organic Marketside - UPC 766342325903, Kroger - UPC 011110181749, Wegmans -
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1578-2020·2020-09-23

    Herbacil Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol

    Broncolin, S.A. de C.V. is recalling Herbacil Antiseptic Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; , Made in Mexico by: Broncolin, S.A. de C.V
    Category
    Drug
    Distribution
    Distributed nationwide

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