The Recall Desk

Archive

May 2021 recalls

517 recalls were announced in May 2021.

What the numbers show

Critical
40
Severe
132
High
234
Moderate
95
Low
16

Of the 517 recalls this month scored against our rubric, 8% are Critical, 26% are Severe.

1–100 of 517

  • SevereNHTSA·21V407000·2021-05-29

    Ford Recalls 2021 F-150 Trucks Due to Steering Gear Defect

    Ford is recalling 2021 F-150 vehicles because internal steering gear damage could cause loss of steering control. Owners should not drive until the repair is complete.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V405000·2021-05-28

    Mercedes-Benz Recalls 2020 GLB 250 Vehicles for Air Bag Defect

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because the front passenger air bag may tear upon deployment, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V406000·2021-05-28

    2021 Mercedes-Benz Cabriolets: Rear Headrests May Be Incorrectly Mounted

    Mercedes-Benz USA is recalling approximately 218 2021 Cabriolet models due to rear headrests that may be incorrectly mounted to the seatbacks. The headrests could move or detach during a crash, increasing the risk of injury.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, E 450, AMG E53, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2021·2021-05-28

    King's Command Foods Recalls Meatballs and Pork Patties for Undeclared Allergens

    King's Command Foods is recalling approximately 20,025 pounds of meatballs and pork patties because they contain undeclared egg, milk, or wheat.

    Product
    King's Command Foods, LLC — King's Command Foods, LLC. Recalls Meat and Poultry Meatballs and Pork Pattie Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·21V403000·2021-05-28

    Mercedes-Benz Recalls 2020 GLB 250 Vehicles for Water Intrusion Defect

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because water may enter the foot wells, potentially causing electrical damage, engine stalls, or a blank instrument cluster.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V404000·2021-05-28

    Mercedes-Benz Recalls 2020 GLB 250 for Side Air Bag Defect

    Mercedes-Benz is recalling 2020 GLB 250 vehicles because side curtain air bags may not deploy properly in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V402000·2021-05-27

    2021 INFINITI QX50 Steering Knuckle Structural Defect - Multiple Models Affected

    Nissan recalls 2021 INFINITI QX50 and other vehicles due to front steering knuckles and rear axle housings with insufficient strength from improper heat treatment, which could deform on impact and cause loss of steering control or wheel separation.

    Product
    INFINITI — INFINITI, NISSAN QX60, MURANO, Q50, GT-R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V401000·2021-05-27

    BMW Recalls 3 Series Vehicles for Air Bag Inflator Defect

    BMW is recalling 1999-2001 3 Series vehicles because the driver-side air bag inflator may explode or underinflate, posing a risk of serious injury.

    Product
    BMW — BMW 330CI, 3 SERIES, 328CI, 330I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V398000·2021-05-27

    RAM 3500, 4500, and 5500 vehicles recalled for wheel stud failure

    Chrysler is recalling RAM trucks because incorrect manual torque specifications can cause wheel studs to over-tighten, break, and lead to wheel separation and possible crashes.

    Product
    RAM — RAM, DODGE 5500, 3500, 4500, RAM 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21750·2021-05-27

    Williams Advanced Materials Recalls Three Chemicals for Packaging and Labeling Violations

    Williams Advanced Materials & Chemicals is recalling sodium hydroxide, heptane, and naphtha because the packaging is not child-resistant and labels violate federal requirements.

    Product
    Williams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21751·2021-05-27

    Umbrosa Pool and Patio Umbrellas Recalled Due to Arm Breakage Hazard

    Umbrosa is recalling about 250 pool and patio umbrellas because the arm can break at the elbow while in use, posing an injury hazard.

    Product
    Umbrosa umbrellas equipped with the Umbrosa Evolution Arm/Holder
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V400000·2021-05-27

    Triple E RV Recalls 2020-2021 Models Due to Refrigerator Exhaust Deflector Issue

    Triple E Recreational Vehicles is recalling 2020-2021 Serenity, Unity, and Wonder models because a low-positioned metal deflector allows exhaust to char the wood frame, increasing fire risk.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, SERENITY, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0539-2021·2021-05-26

    Natural Way Almond Butter Recalled for Potential Undeclared Peanuts

    Simkins Brothers Sweets is recalling Natural Way Almond Butter due to potential undeclared peanuts. Consumers should check for lot #505721.

    Product
    Natural Way Almond Butter 16 oz. UPC 850001775175 packaged in clear plastic jars
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0503-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Isolate for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate dietary supplements because FDA inspections found undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE NEOPOLITAN ICE CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 8 11836 02251 3 & 5lb, UPC 8 11836 02252 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0381-2021·2021-05-26

    FDA Recalls PremierZen Extreme 3000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Extreme 3000 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2021·2021-05-26

    Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0388-2021·2021-05-26

    Thumbs Up 7 Blue 69K Recalled for Unapproved Sildenafil and Tadalafil

    Bit & Bet LLC is recalling Thumbs Up 7 Blue 69K capsules because FDA analysis found unapproved sildenafil and tadalafil.

    Product
    Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0549-2021·2021-05-26

    Faribault Foods Recalls O Organics Organic Black Beans Due to Seal Defects

    Faribault Foods is recalling O Organics Organic Black Beans because of compromised hermetic seals on the cans. Consumers should check their pantry for the specific UPC and best-by date.

    Product
    O Organics Organic Black Beans, 15 oz. can, UPC 0-79893-40610-7 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, 1-800-232-4271
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0374-2021·2021-05-26

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.

    Product
    Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 194
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V392000·2021-05-26

    Freightliner Recalls 2019 M2 Business Class Vehicles for Electrical Defect

    Daimler Trucks North America is recalling 2019 Freightliner M2 Business Class vehicles with 14Xe ePowertrains because insufficiently crimped stator wires may cause overheating and loss of drive power.

    Product
    FREIGHTLINER — FREIGHTLINER M2 BUSINESS CLASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2021·2021-05-26

    Pfizer Recalls Sterile Water Vials Due to Insect Particulate Matter

    Pfizer is recalling 49,525 vials of Sterile Water for Injection because an insect was found in one vial. The product is distributed nationwide.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2021·2021-05-26

    Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination

    Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0382-2021·2021-05-26

    FDA Recalls PremierZen Black 5000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Black 5000 capsules because FDA analysis detected the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0378-2021·2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee the product is sterile.

    Product
    Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2021·2021-05-26

    Teva Recalls Metoclopramide Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Metoclopramide Injection because there is a lack of assurance of sterility. The product was distributed nationwide.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2021·2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2021·2021-05-26

    Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns

    Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0510-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls iFORCE Protein Matrix for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling iFORCE Nutrition Mass Gainz Protein Matrix due to undeclared egg, milk, wheat, and soy.

    Product
    IFN iFORCE NUTRITION MASS GAINZ PROTEIN MATRIX BROWN SUGAR MAPLE OATMEAL COOKIE NET WT 2.2 KG/4.85 LBS container UPC 8 19500 01010 1 Mfg. For Dist. By Trib?????? Enterprises, LLC Vista, CA 92081
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1644-2021·2021-05-26

    Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns

    Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.

    Product
    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2021·2021-05-26

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets

    Preferred Pharmaceuticals is recalling specific lots of Metformin HCl Extended Release tablets due to the presence of NDMA impurity exceeding safety limits.

    Product
    Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0545-2021·2021-05-26

    Basic Grain Products Recalls Caramel Rice Cakes Due to Undeclared Milk

    Basic Grain Products Inc is recalling Caramel Rice Cakes sold under Kroger and Stop & Shop brands because the product contains undeclared milk.

    Product
    Caramel Rice Cakes 6.56oz (186g) 12 units per case 14 rice cakes per packaging Brands: Kroger Brand and Stop & Shop Brand
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1635-2021·2021-05-26

    Biopsybell Cement Mixing System Recalled for Potential Sterility Failure

    Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.

    Product
    CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0383-2021·2021-05-26

    FDA Recalls Triple SupremeZen Plus 3500 for Unapproved Tadalafil

    Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0497-2021·2021-05-26

    A Life African Market Recalls Unlabeled Shrayy Chalk for Lead and Arsenic

    A Life African Market Corp is recalling 344 lbs of unlabeled Shrayy white chalk found to contain elevated levels of lead and arsenic. The product was distributed in New York, Delaware, Massachusetts, and Pennsylvania.

    Product
    Shrayy (white chalk) packaged in .68lb bags of synthetic plastic; no label on packaging
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0499-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph 28 Pure Whey Isolate for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Chocolate Fudge Pop dietary supplements because FDA inspections found undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071 UPC 8 11836 02223 0
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0390-2021·2021-05-26

    Lupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide

    Lupin Pharmaceuticals is voluntarily recalling 3,138 bottles of Cefixime for Oral Suspension because the drug is subpotent. The affected product was distributed nationwide in the United States.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V396000·2021-05-26

    2022 Thor Motor Coach RV models recalled for solar panel fire risk

    Thor Motor Coach is recalling certain 2022 Sequence, Rize, Scope, and Tellaro recreational vehicles. The Flex-190 solar panel junction box may experience electrical shorts, increasing the fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH RIZE, SCOPE, SEQUENCE, TELLARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2021·2021-05-26

    Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns

    Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0505-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph Whey Protein for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Smores dietary supplement because it contains undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE SMORES DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89002 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • SevereCPSC·21138·2021-05-26

    HSN Recalls 5.4 Million Handheld Clothing Steamers Due to Burn Hazard

    HSN is recalling 5.4 million Joy/JM-branded My Little Steamer handheld clothing steamers because they can expel hot water, posing a serious burn hazard.

    Product
    Joy/JM-branded My Little Steamer® and My Little Steamer® Go Mini
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2021·2021-05-26

    BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

    BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

    Product
    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns

    Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1592-2021·2021-05-26

    Boston Scientific Recalls VICI RDS Venous Stent System Due to Migration

    Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.

    Product
    VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0547-2021·2021-05-26

    FDA Recall: Enoki Mushrooms Tested Positive for Listeria Monocytogenes

    Massachusetts sampling detected Listeria monocytogenes in Guan's Enoki Mushrooms, prompting a nationwide recall.

    Product
    Guan's Enoki Mushroom; Champignon d'enoki 100 g/3.5 oz. and 200 g/7 oz. packages. Clear package with blue band at bottom of front and back of package. UPC 100g: 859267007020; UPC 200g: 810023170303. Keep refrigeratedL Distributed by Guan's Mushroom, Los Angeles, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference

    Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate, elevated glucose readings.

    Product
    Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1654-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate glucose readings.

    Product
    Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1658-2021·2021-05-26

    Bard Access Systems Recalls Replacement Connectors for Groshong NXT PICC Catheters

    Bard Access Systems is recalling specific replacement connectors for Groshong NXT PICC catheters due to manufacturing defects that may prevent proper catheter passage or locking.

    Product
    REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose l
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1622-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Mold Contamination

    Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1634-2021·2021-05-26

    BPB medica Osteobell Explant Needle Recalled for Sterility Concerns

    BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.

    Product
    BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2021·2021-05-26

    Roche Recalls Troponin I STAT Immunoassay Kits Due to False Negative Risk

    Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.

    Product
    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.

    Product
    Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing sy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1663-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference

    Medtronic is recalling Guardian Sensor 3 kits because use with the drug hydroxyurea may cause inaccurate, elevated glucose readings.

    Product
    Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1594-2021·2021-05-26

    WillowWood Alpha Interlock Suspension System Lanyard Body Recalled for Pin Defect

    WillowWood Global LLC is recalling 815 Alpha Interlock Suspension System Lanyard Bodies because a shorter dowel pin was used, which may cause the suspension cord to slip or come loose.

    Product
    Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lany
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2021·2021-05-26

    Roche Recalls Troponin I Immunoassay Kits Due to False Negative Risk

    Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.

    Product
    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recall for Hydroxyurea Interaction

    Medtronic is recalling 207 units of Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated glucose readings.

    Product
    Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabet
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1646-2021·2021-05-26

    Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure

    Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·21139·2021-05-26

    Ergobaby Recalls METROUS Strollers Due to Choking Hazard

    Ergobaby is recalling METROUS strollers because a harness buckle button can break and detach, posing a choking hazard to young children.

    Product
    METROUS1, METROUS2 and METROUS4 Compact City Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose le
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21V393000·2021-05-26

    Grand Design RV Travel Trailers LP Regulator Fire Risk Recall

    Grand Design is recalling 55,508 travel trailers (2016-2021 Imagine, Transcend, Momentum) for defective LP regulators that may cause excessive gas pressure and increase fire risk. Free replacement available through dealers.

    Product
    GRAND DESIGN — GRAND DESIGN IMAGINE, MOMENTUM, TRANSCEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0546-2021·2021-05-26

    South Georgia Pecan Company Recalls Pecan Halves Due to Peanut Complaints

    South Georgia Pecan Company is recalling 30-pound cases of Fancy Seed Pecan Halves because consumers reported finding peanuts in the product.

    Product
    FANCY SEED PECAN HALVES 750 STERILIZED NET WT 30.00 Ingredients: Pecans Allergens: Pecans SOUTH GEORGIA PECAN Co. P.O.. Box 5366 Valdosta, GA 31603 800-627-6630
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1632-2021·2021-05-26

    Biopsybell Recalls Sterile Spine Bone Filler Due to Sterilization Concerns

    Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.

    Product
    RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth

    Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0537-2021·2021-05-26

    PepsiCo Recalls Evolve Protein Shakes Due to Undeclared Soy

    PepsiCo is recalling Evolve Double Chocolate Plant-Based Protein Shakes because they contain undeclared soy. The recall covers 17,381 cases distributed nationwide.

    Product
    Evolve Double Chocolate Plant-Based Protein Shake, 11oz "Tetra Pak" carton, sold 4 cartons per retail unit. UPC on retail 4 pack: 876063007887 Packed 3 retail four packs per wholesale case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V395000·2021-05-26

    2017–2021 Holiday Rambler and Fleetwood Motorhomes Recalled for Improperly Sealed Flooring

    REV Recreation Group is recalling 2017–2021 Fleetwood, Holiday Rambler, and Fleetwood motorhomes with improperly sealed floor holes that could allow carbon monoxide into the living area. Dealers will reseal the floor free of charge.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER, BOUNDER, SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0498-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Banana Cream Pie dietary supplements because FDA inspections found undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE BANANA CREAM PIE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89846 7 & 5LB, UPC 6 49241 87829 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • HighFDA (Food)·F-0504-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate dietary supplements because FDA inspections found undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE ORANGE CREAMSICLE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89856 6 & 5lb, UPC 6 49241 87833 9 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-1669-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects that may prevent proper catheter passage or locking.

    Product
    REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0536-2021·2021-05-26

    Russ Davis Wholesale Recalls Veggie Pizza for Undeclared Soy Lecithin

    Russ Davis Wholesale Inc. is recalling 536 units of Veggie Pizza sold in six states because the product contains undeclared soy lecithin.

    Product
    Veggie Pizza sold under the following brands: Crazy Fresh, quick & easy, and blank label. Item # 81068, Net Wt. 6.2 oz., UPC 7 95631 81068 4. Keep Refrigerated. Manufactured By: RDW St. Paul, MN 55121
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0535-2021·2021-05-26

    Wolfie's Crunchy Cheddar & Jalapeno Peanuts Recalled for Undeclared Milk

    Wolfies Group Inc is recalling Crunchy Cheddar & Jalapeno Peanuts due to undeclared milk on the label. The product was distributed across all 50 states.

    Product
    Wolfie's Crunchy Cheddar & Jalapeno Peanuts Packaged in a Rice Paper Stand Up Pouch with Clear Poly Plastic Bag inside 5oz - 12 bags per case 14oz - 6 bags per case 28oz - 4 bags per case 80oz sold as individual bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1636-2021·2021-05-26

    Biopsybell Easynject Device Recalled for Potential Sterility Failure

    Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.

    Product
    EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V391000·2021-05-26

    Heavy-duty trucks recalled for fuel rail defect and fire risk

    PACCAR is recalling certain 2018-2021 Kenworth and Peterbilt commercial trucks because a sealing washer defect in the fuel rail assembly may cause fuel leaks. When fuel leaks occur near an ignition source, fire risk increases.

    Product
    PETERBILT — PETERBILT, KENWORTH 367, 337, 567, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor gluc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1611-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1610-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate elevated glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1650-2021·2021-05-26

    Medtronic Recalls Two Defective Implantable Cardioverter Defibrillators

    Medtronic is recalling two Cobalt HF Quad MRI SureScan CRT-D devices due to a potential missing resistance spot weld.

    Product
    Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2021·2021-05-26

    Biopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns

    Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.

    Product
    10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0496-2021·2021-05-26

    White Oak Pear Gorgonzola Salad Dressing Recalled for Undeclared Sulfites

    Global Palate Foods is recalling White Oak Farm & Table Pear Gorgonzola Salad Dressing because the product contains undeclared sulfites from Dijon mustard and red wine vinegar.

    Product
    White Oak Farm & Table brand Pear Gorgonzola Salad Dressing & Dipping Sauce; 12 Fl OZ, packaged in glass bottles
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0542-2021·2021-05-26

    Bloommy Biotin Collagen Keratin Capsules Recalled for Undeclared Fish

    Bloommy Inc. is recalling Biotin Collagen Keratin Capsules because they contain undeclared fish collagen, a potential allergen.

    Product
    "Bloomy*** Biotin Collagen Keratin***Capsules for SKIN, JOINT, HAIR***Supplement Facts***Marine Collagen***Manufactured for Bloommy Inc. 106 W. Broad St. Pawcatuck, CT 06379"
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0492-2021·2021-05-26

    Desserts On Us Baklava Recalled for Undeclared Milk Allergen

    Desserts On Us, Inc. is recalling 264 units of Original Traditional Baklava because the label failed to declare milk, a major allergen.

    Product
    Desserts On Us Original Traditional Baklava: Net Wt. 4 oz., (113g) UPC: 7 59098 51001 3 Desserts On Us, 57 Belle Falor Court, Arcata, CA 95521 Ingredients: Almonds, Sugar, filo dough [wheat flour(enriched with niacin, iron, thiamine mononitrate, riboflavin, folic acid)
    Category
    Food
    Distribution
    2 states
  • HighCPSC·21141·2021-05-26

    Target Recalls Room Essentials Shower Stools Due to Fall Hazard

    Target is recalling Room Essentials Shower Stools because they can become unstable or slippery, posing a fall hazard. About 58,500 units were sold.

    Product
    Room Essentials Shower Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0552-2021·2021-05-26

    Udi Gluten Free Chocolate Zucchini Muffins Recalled for Plastic Contamination

    Conagra Brands is recalling Udi Gluten Free Chocolate Zucchini Muffins due to the potential presence of plastic. Consumers should stop eating the product.

    Product
    Udi Gluten Free Chocolate Zucchini Muffins, 10oz retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81014-8
    Category
    Food
    Distribution
    Distributed nationwide

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