The Recall Desk

Archive

April 2021 recalls

449 recalls were announced in April 2021.

What the numbers show

Critical
28
Severe
123
High
196
Moderate
90
Low
12

Of the 449 recalls this month scored against our rubric, 6% are Critical, 27% are Severe.

Which agencies issued them

201–300 of 449

  • ModerateFDA (Devices)·Z-1424-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled Due to Growth Issues

    Remel Inc is recalling 408 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 960 containers of Lite'n Foamy Healthcare Personnel Handwash due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH — LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy E2 Sanitizing Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 2,152 containers of Lite'n Foamy E2 Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    LITE NFOAMY E2 SANITIZING HANDWASH — LITE NFOAMY E2 SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2021·2021-04-21

    Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents for Sealed Tube Defect

    Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System because rehydration buffer tubes were not adequately sealed, potentially causing unresolved test results.

    Product
    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2021·2021-04-21

    Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

    Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0333-2021·2021-04-21

    Jubilant Cadista Recalls Itraconazole Capsules Due to Dissolution Failures

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Itraconazole Capsules, 100 mg, because they failed to meet dissolution specifications.

    Product
    Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2021·2021-04-21

    Biomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues

    Biomerieux is recalling VIDAS CMV IgM test kits due to reported calibration issues. The recall affects 18,705 kits distributed nationwide and internationally.

    Product
    VIDAS¿ CMV IgM 30 Tests
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1430-2021·2021-04-21

    Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors

    Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.

    Product
    MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1429-2021·2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2021·2021-04-21

    Centinel Spine Recalls Prodisc C Devices Missing Orientation Marking

    Centinel Spine is recalling 49 Prodisc C cervical disc prostheses because the 'UP' orientation marking is missing from the superior plate.

    Product
    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2021·2021-04-21

    Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

    Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

    Product
    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2021·2021-04-21

    Vectornate Recalls MedSchenker Smart Transport Medium Due to Discoloration

    Vectornate USA Inc is recalling 130,000 MedSchenker Smart Transport Medium systems due to discoloration and turbidity caused by a longer monsoon season at the manufacturing facility.

    Product
    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0331-2021·2021-04-21

    Teligent Pharma Recalls Lidocaine Ointment for Failed Stability Specifications

    Teligent Pharma is recalling Lidocaine Ointment USP, 5%, due to failed viscosity specifications. The recall covers 62,040 tubes distributed nationwide.

    Product
    Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0330-2021·2021-04-21

    Enovachem Recalls Methylprednisolone Tablets Due to Illegible Labeling

    Enovachem Pharmaceuticals is recalling Methylprednisolone Tablets due to misaligned printing on the blister card that renders dosing instructions illegible.

    Product
    Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03…
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·21E032000·2021-04-20

    Cummins Diesel Engine Fuel Rail Recall for Fire Risk

    Cummins is recalling specific L9 and ISX12 diesel engines because a sealing washer defect may cause fuel leaks, increasing the risk of fire.

    Product
    FUEL SYSTEM, DIESEL:FUEL INJECTION SYSTEM:FUEL RAIL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V269000·2021-04-20

    Manac Recalls 2018-2019 Trailers Due to Potential Steering Arm Detachment

    Manac is recalling 2018-2019 Steel Platforms, Transfer Trailers, and Square Dump Trailers because steer arm bolts may break, allowing the arm to detach and drag.

    Product
    MANAC — MANAC SQUARE DUMP TRAILER, STEEL PLATFORM, TRANSFER TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·013-2021·2021-04-16

    JBS Recalls Imported Boneless Beef for E. coli O157:H7 Contamination

    JBS USA is recalling approximately 4,860 pounds of imported boneless beef products due to possible E. coli O157:H7 contamination. The raw, frozen beef was distributed to processors in New York and Pennsylvania.

    Product
    JBS USA Food Company Recalls Imported Boneless Beef Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·21E030000·2021-04-16

    TSE Brakes Recalls Omni Tandem Brake Chambers Due to Spring Defect

    TSE Brakes is recalling certain Omni Tandem Brake Chambers because incorrect springs may cause the pressure plate to shift, potentially leading to a loss of air pressure and increased crash risk.

    Product
    PARKING BRAKE:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E029000·2021-04-16

    Daimler Trucks Recalls Detroit Axles Due to Steering Bolt Defect

    Daimler Trucks North America is recalling Detroit Model 2 and 3 axles because steering arm and tie rod bolts may fracture, potentially causing a loss of steering.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E028000·2021-04-16

    Meritor Recalls 14Xe ePowertrains Due to Electrical System Defect

    Meritor is recalling specific 14Xe ePowertrains because insufficiently crimped stator wires may cause overheating and loss of motive power, increasing crash risk.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V267000·2021-04-16

    Pioneer Recalls Prevost H3 and X3 Buses for Fire Risk

    Pioneer Coach Interiors is recalling 2019-2020 Prevost H3 and X3 vehicles because a damaged circuit board increases the risk of a fire.

    Product
    PREVOST — PREVOST H3, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2021·2021-04-15

    Olymel Recalls Ready-to-Eat Ham Due to Salmonella Enteritidis Contamination

    Olymel S.E.C./L.P. is recalling approximately 6,804 pounds of ready-to-eat ham products due to possible Salmonella Enteritidis contamination. The products were shipped to distributors in California for institutional use.

    Product
    Olymel S.E.C./L.P. Recalls Ready-to-Eat Ham Products Due to Possible Salmonella Enteritidis Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21V266000·2021-04-15

    2022 Thomas Built Buses Minotour Recalled for Electrical Fire Risk

    Daimler Trucks North America is recalling 2022 Thomas Built Buses Minotour vehicles because battery cable terminals may contact a fuse block, causing an electrical short circuit and increasing fire risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V263000·2021-04-15

    Subaru Recalls Crosstrek and Forester for Rear Stabilizer Bolt Defect

    Subaru is recalling 2018-2019 Crosstrek and 2019 Forester vehicles because rear stabilizer bracket bolts may loosen and detach, increasing crash risk.

    Product
    SUBARU — SUBARU CROSSTREK, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V265000·2021-04-15

    2021 Tiffin Phaeton Motorhomes: Roof Panel Detachment Hazard

    Tiffin is recalling certain 2021 Phaeton motorhomes with roof-mounted awnings. A roof mounted body panel may be improperly attached and could detach, becoming a road hazard and increasing crash risk.

    Product
    TIFFIN — TIFFIN PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V264000·2021-04-15

    Subaru Recalls Impreza and Crosstrek for Ignition Coil Short Circuit Risk

    Subaru is recalling 2017-2019 Impreza and 2018-2019 Crosstrek vehicles because the engine control module may keep the ignition coil powered after shutdown, causing a short circuit and potential stall.

    Product
    SUBARU — SUBARU CROSSTREK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0405-2021·2021-04-14

    MG Foods Recalls Turkey Pitas Due to Listeria Contamination

    Canteen Inc. dba MG Foods, Inc. is recalling Fresh To You Turkey & Sundried Tomato Mayo Pitas due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey & Sundried Tomato Mayo Pita, Net Wt. 8.29oz (235g), MG Foods Charlotte, NC 28208, UPC MGF9806
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0397-2021·2021-04-14

    MG Foods Recalls Ham and Turkey Sandwiches for Listeria Risk

    Canteen Inc. dba MG Foods, Inc. is recalling Fresh To You Ham & Turkey Combo sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Ham & Turkey Combo, Net Wt. 5.85oz (168g), MG Foods Charlotte, NC 28208, UPC MGF3054 & MGF23054
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0409-2021·2021-04-14

    MG Foods Recalls Turkey and Swiss Sandwiches Due to Listeria Risk

    Canteen Inc. dba MG Foods is recalling 195 Turkey & Swiss sandwiches after positive Listeria monocytogenes test results were found during in-house environmental sampling.

    Product
    FRESH TO YOU Turkey & Swiss on Whole Wheat Roll, Net Wt. 5.22oz (148g), MG Foods Charlotte, NC 28208, UPC MGF0854
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0399-2021·2021-04-14

    MG Foods Recalls Fresh To You Turkey And Cheese Sub For Listeria

    Canteen Inc. dba MG Foods, Inc. is recalling 278 Fresh To You Large Turkey & Cheese Subs due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Large Turkey & Cheese Sub, Net Wt. 6.74oz (191g), MG Foods Charlotte, NC 28208, UPC MGF1002
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0421-2021·2021-04-14

    MG Foods Recalls Deluxe Club Wraps Due to Listeria Risk

    Canteen Inc. dba MG Foods, Inc. is recalling 127 Deluxe Club Wraps due to positive Listeria monocytogenes test results on a meat slicer.

    Product
    FRESH TO YOU Deluxe Club Wrap, Net Wt. 10.39oz (295g), MG Foods Charlotte, NC 28208, UPC MGF9814
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0395-2021·2021-04-14

    MG Foods Recalls Club Sub Sandwiches for Listeria Risk

    Canteen Inc. dba MG Foods is recalling 34 Club Sub sandwiches due to positive Listeria monocytogenes test results on a meat slicer.

    Product
    FRESH TO YOU Club Sub with Italian Dressing, Net Wt. 9.14oz (259g), MG Foods Charlotte, NC 28208, UPC MGF9100
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0419-2021·2021-04-14

    MG Foods Turkey and Provolone Sandwiches Recalled for Listeria Risk

    MG Foods is recalling 10-count packs of Turkey & Provolone sandwiches due to positive Listeria monocytogenes test results on a meat slicer.

    Product
    MG Foods TURKEY & PROVOLONE ON 12 GRAIN WITH LETTUCE, TOMATO AND MAYONNAISE, Net Wt. 8.9oz (255g), MG Foods Charlotte, NC 28208, UPC 1 00000 50066 8
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0408-2021·2021-04-14

    MG Foods Recalls Fresh To You Turkey Sandwiches Due To Listeria Risk

    Canteen Inc. dba MG Foods is recalling 319 Fresh To You Turkey & Swiss sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey & Swiss on Wheat, Net Wt. 3.9oz (112g), MG Foods Charlotte, NC 28208, UPC MGF0283
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0422-2021·2021-04-14

    MG Foods Recalls Roasted Turkey Wraps Due to Listeria Risk

    MG Foods is recalling 192 roasted turkey wraps because Listeria monocytogenes was detected during in-house environmental sampling on a meat slicer.

    Product
    MG Foods ROASTED TURKEY IN A TOMATO BASIL WRAP, Net Wt. 6.9oz (196g), MG Foods Charlotte, NC 28208, UPC 1 00000 50005 7
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0404-2021·2021-04-14

    MG Foods Recalls Turkey and Cheese Hoagies Due to Listeria

    Canteen Inc. dba MG Foods, Inc. is recalling FRESH TO YOU Turkey & Cheese Hoagies due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey & Cheese Hoagie, Net Wt. 6.35oz (180g), MG Foods Charlotte, NC 28208, UPC MGF0597
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0394-2021·2021-04-14

    MG Foods Recalls Club Panini Due to Listeria Contamination

    MG Foods is recalling 67 Club Panini sandwiches due to positive Listeria monocytogenes test results. The product was distributed in Georgia, North Carolina, South Carolina, and West Virginia.

    Product
    FRESH TO YOU Club Panini, Net Wt. 8.50oz (241g), MG Foods Charlotte, NC 28208, UPC MGF9844
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0403-2021·2021-04-14

    MG Foods Recalls Fresh To You Turkey And Cheese Sandwiches

    Canteen Inc. dba MG Foods, Inc. is recalling 566 Fresh To You Turkey & Cheese Cut sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey & Cheese Cut, Net Wt. 6.56oz (186g), MG Foods Charlotte, NC 28208, UPC MGF0596
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0418-2021·2021-04-14

    MG Foods Turkey and Provolone BLT Croissant Sandwiches Recalled for Listeria

    Canteen Inc. dba MG Foods, Inc. is recalling 65 Turkey & Provolone BLT on a Buttery Croissant sandwiches due to positive Listeria monocytogenes test results.

    Product
    MG Foods TURKEY & PROVOLONE BLT ON A BUTTERY CROISSANT, Net Wt. 8.1oz (229g), MG Foods Charlotte, NC 28208, UPC 1 00000 50065 1
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0400-2021·2021-04-14

    MG Foods Recalls Fresh To You Market Club Sandwiches for Listeria

    MG Foods is recalling 75 Fresh To You Market Club sandwiches due to positive Listeria monocytogenes test results on a meat slicer.

    Product
    FRESH TO YOU Market Club, Net Wt. 11.85oz (336g), MG Foods Charlotte, NC 28208, UPC MGF9800
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0412-2021·2021-04-14

    MG Foods Recalls Turkey Swiss Pitas Due to Listeria Risk

    Canteen Inc. dba MG Foods is recalling Fresh To You Turkey Swiss & Cranberry Mayo Pitas after positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey Swiss & Cranberry Mayo Pita, Net Wt. 9oz (255g), MG Foods Charlotte, NC 28208, UPC MGF9804
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0414-2021·2021-04-14

    MG Foods deli sandwich recalled due to Listeria monocytogenes contamination in meat slicer

    The FDA recalled MG Foods chilled deli sandwiches after detecting Listeria monocytogenes during internal testing of a meat slicer.

    Product
    MG Foods CHEDDAR HALF AND HALF TURKEY & CHEDAR WITH TOMATO AIOLI AND A SIDE OF SPRING MIX, Net Wt. 7.7oz (218g), MG Foods Charlotte, NC 28208, UPC 1 00000 50069 9
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0396-2021·2021-04-14

    MG Foods Recalls Fresh To You Deluxe Triple Decker Club Sandwiches

    Canteen Inc. dba MG Foods, Inc. is recalling 379 Fresh To You Deluxe Triple Decker Club sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Deluxe Triple Decker Club, Net Wt. 12.17 oz (345g), MG Foods Charlotte, NC 28208, UPC MGF9719
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0410-2021·2021-04-14

    FRESH TO YOU Turkey Club Croissant Recall Due to Listeria Detection

    Canteen Inc. is recalling Fresh To You Turkey Club Croissants because Listeria monocytogenes was found during environmental testing of their meat slicers.

    Product
    FRESH TO YOU Turkey Club Croissant, Net Wt. 7.94oz (225g), MG Foods Charlotte, NC 28208, UPC MGF9103
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0413-2021·2021-04-14

    MG Foods Recalls Tuscan Turkey Ciabatta Due to Listeria Risk

    Canteen Inc. dba MG Foods is recalling FRESH TO YOU Tuscan Turkey Ciabatta sandwiches because they tested positive for Listeria monocytogenes during environmental sampling.

    Product
    FRESH TO YOU Tuscan Turkey Ciabatta, Net Wt. 9.18 oz (264g), MG Foods Charlotte, NC 28208, UPC MGF9810
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0320-2021·2021-04-14

    Sun Pharmaceutical Recalls Ganirelix Acetate Injection Due to Impurities

    Sun Pharmaceutical Industries is recalling 91,211 syringes of Ganirelix Acetate Injection because the product failed impurities and degradation specifications.

    Product
    Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0390-2021·2021-04-14

    Whole Foods Market Cranberry Biscotti Recalled for Undeclared Pistachios

    Whole Foods Market is recalling Cranberry Biscotti (PLU 41712) because the product contains undeclared pistachios, a major tree nut allergen.

    Product
    Whole Foods Market Cranberry Biscotti PLU 41712 packaged in a clear plastic clam shell container
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0417-2021·2021-04-14

    MG Foods Turkey and Pepperjack Sandwiches Recalled for Listeria

    MG Foods is recalling Turkey & Pepperjack sandwiches due to positive Listeria monocytogenes test results found during environmental sampling.

    Product
    MG Foods TURKEY & PEPPERJACK ROASTED TURKEY, PEPPERJACK, CHIPOTLE MAYO, LETTUCE AND TOMATO ON A FRESH SUB ROLL, Net Wt. 7.9oz (224g), MG Foods Charlotte, NC 28208, UPC 1 00000 50055 2
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1340-2021·2021-04-14

    Medtronic HVAD Battery Recall for Potential Controller Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1332-2021·2021-04-14

    Tenacore Alaris Infusion Pump Bezel Recall for Cracking Risk

    Tenacore LLC is recalling Alaris Infusion Pump 8100 bezels because they may crack or separate, potentially causing infusion errors.

    Product
    Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1341-2021·2021-04-14

    Medtronic HVAD Monitor Recall Due to Cable Port Damage Risk

    Heartware is recalling Medtronic HVAD Packaged Monitors because worn cables may damage controller ports during insertion.

    Product
    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0401-2021·2021-04-14

    Fresh To You Shaved Turkey & Cheese Recalled Due to Listeria Contamination

    Fresh To You Shaved Turkey & Cheese was recalled because Listeria monocytogenes was detected in a meat slicer during testing.

    Product
    FRESH TO YOU Shaved Turkey & Cheese, Net Wt. 4.55oz (129g), MG Foods Charlotte, NC 28208, UPC MG5571 & MGF25571
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0411-2021·2021-04-14

    MG Foods Recalls Turkey Melt Croissants Due to Listeria Risk

    Canteen Inc. dba MG Foods, Inc. is recalling FRESH TO YOU Turkey Melt Croissants after positive Listeria monocytogenes test results were found during environmental sampling.

    Product
    FRESH TO YOU Turkey Melt Croissant, Net Wt. 6.7oz (190g), MG Foods Charlotte, NC 28208, UPC MGF3032
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0386-2021·2021-04-14

    Sabra Classic Hummus Recalled for Potential Salmonella Contamination

    Sabra Dipping Company is recalling 10-ounce cups of Classic Hummus due to potential Salmonella contamination. The product was distributed to 11 states.

    Product
    Sabra Dipping Co, Classic Hummus ,10oz. PET cup, sealed with lid, 12 ct. Manufacturing Codes 300067. Expiration date 4/26/21
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0402-2021·2021-04-14

    Fresh To You Turkey & Cheddar Club sandwich recall due to Listeria contamination

    MG Foods' Fresh To You turkey and cheddar club sandwich was recalled because Listeria monocytogenes was detected on a meat slicer during internal testing.

    Product
    FRESH TO YOU Turkey & Cheddar Club on Wheat, Net Wt. 10.02oz (284g), MG Foods Charlotte, NC 28208, UPC MGF9710
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1337-2021·2021-04-14

    Medtronic HVAD Controller Power Cables Recalled for Port Damage Risk

    Heartware, Inc. is recalling Medtronic HVAD Controller power and data cables due to a risk of damaging controller ports from cable misalignment.

    Product
    Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0407-2021·2021-04-14

    FRESH TO YOU Turkey & Swiss Meat Slices Recalled Due to Listeria Contamination

    The FDA is recalling Fresh To You Turkey & Swiss on Kaiser meat slices because testing found Listeria monocytogenes in a meat slicer.

    Product
    FRESH TO YOU Turkey & Swiss on Kaiser, Net Wt. 8.11oz (230g), MG Foods Charlotte, NC 28208, UPC MGF9712
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1339-2021·2021-04-14

    Medtronic HVAD Monitor Data Cable Recalled for Potential Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables because they may damage HVAD Controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Monitor Data Cable, Product Number: 1575
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1331-2021·2021-04-14

    Tenacore Recalls Alaris Infusion Pump Modules with Impacted Bezel Repair Parts

    Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, potentially causing infusion errors.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Food)·F-0383-2021·2021-04-14

    Bobo's Maple Pecan Oat Bars Recalled for Peanut Complaints

    Simply Delicious Inc. is recalling Bobo's Maple Pecan Oat Bars due to consumer complaints regarding the presence of peanuts.

    Product
    Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best By 7/30/21 or 7/31/21.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1336-2021·2021-04-14

    Medtronic HVAD Controller Recall for Potential Port Damage

    Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0398-2021·2021-04-14

    MG Foods Recalls Fresh To You Ham and Turkey Sandwiches for Listeria

    Canteen Inc. dba MG Foods, Inc. is recalling 165 Fresh To You Ham & Turkey Combo sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Ham & Turkey Combo on 12 Grain, Net Wt. 7.20oz (204g), MG Foods Charlotte, NC 28208, UPC MGF6011
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0415-2021·2021-04-14

    MG Foods Club Sub Sandwiches Recalled for Listeria Risk

    MG Foods is recalling Club Sub sandwiches due to positive Listeria monocytogenes test results on a meat slicer.

    Product
    MG Foods THE CLUB SUB ROAST BEEF, TURKEY, HAM & BABY SWISS WITH GOLDEN ITALIAN DRESSING ON MULTI-GRAIN BATARD, Net Wt. 8.5oz (242g), MG Foods Charlotte, NC 28208, UPC 1 00000 50002 6
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1338-2021·2021-04-14

    Medtronic HVAD Alarm Adapter Recalled for Potential Port Damage

    Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.

    Product
    Medtronic HVAD Alarm Adapter, Product Number: 1450
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0326-2021·2021-04-14

    Alembic Pharmaceuticals Recalls Telmisartan Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling 12,288 bottles of Telmisartan 20 mg tablets due to a label mixup. The product was distributed nationwide in the United States.

    Product
    TELMISARTAN — TELMISARTAN (TELMISARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0406-2021·2021-04-14

    MG Foods Recalls Turkey and Swiss Sandwiches for Listeria Risk

    Canteen Inc. dba MG Foods is recalling 58 Fresh To You Turkey & Swiss sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Turkey & Swiss on Honey Brown Sub Roll, Net Wt. 9.42oz (267g), MG Foods Charlotte, NC 28208, UPC MGF9703
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1343-2021·2021-04-14

    Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0420-2021·2021-04-14

    MG Foods Turkey & Swiss Croissant Recalled Due to Listeria Monocytogenes Contamination

    The FDA is recalling MG Foods Turkey & Swiss On a Buttery Croissant because Listeria monocytogenes was detected during environmental testing of their meat slicers.

    Product
    MG Foods TURKEY & SWISS ON A BUTTERY CROISSANT, Net Wt. 7.5oz (216g), MG Foods Charlotte, NC 28208, UPC 1 00000 50011 8
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0423-2021·2021-04-14

    MG Foods Spinach Wraps Recalled for Listeria Contamination

    MG Foods is recalling The Club in a Spinach Wrap due to Listeria monocytogenes detected in environmental sampling.

    Product
    MG Foods THE CLUB IN A SPINACH WRAP, Net Wt. 8.5oz (244g), MG Foods Charlotte, NC 28208, UPC 1 00000 50008 8
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1378-2021·2021-04-14

    Becton Dickinson Recalls Martin-Lewis Agar Due to Fungal Growth

    Becton Dickinson is recalling Martin-Lewis Agar plates because they show heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2021·2021-04-14

    Arrow OnControl Bone Lesion Biopsy System Recalled for Insertion Defect

    Arrow International is recalling OnControl Bone Lesion Biopsy Systems because the ejector rod may not insert properly, preventing sample collection.

    Product
    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21111·2021-04-14

    Target Recalls Cat & Jack Baby Rompers Due to Choking Hazard

    Target is recalling Cat & Jack Baby Heart Ears Rompers because heart-shaped graphics on the knees can detach, posing a choking hazard to children.

    Product
    Cat & Jack Baby Heart Ears Rompers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2021·2021-04-14

    Quaker Rice Crisps Recalled for Undeclared Soy Allergen

    The Quaker Oats Company is recalling Quaker Rice Crisps Sweet Barbecue Flavor due to undeclared soy. The recall covers 4,550 bags distributed to 21 states.

    Product
    Quaker Rice Crisps Sweet Barbecue Flavor, 3.03 oz. bag, UPC 0 30000 31984 0
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0389-2021·2021-04-14

    Trident Seafoods Pacific Salmon Burgers Recalled for Metal Fragment

    Trident Seafoods is recalling frozen Pacific Salmon Burgers sold at Costco due to a metal fragment found in the product.

    Product
    Trident Seafoods Pacific Salmon Burgers (# 414469), frozen. Costco item #502497. Each retail bag contains of 12/4oz. pieces. Retail bag net wt. 48 oz (3 lb or 1.36 kg). Retail bag UPC 0 28029 14469 7. Each Master case contains of 12/3 lbs. packages. The MASTER CASE label is…
    Category
    Food
    Distribution
    3 states
  • HighCPSC·21112·2021-04-14

    Playgro Recalls Clip Clop Infant Activity Rattles Due to Choking Hazard

    Playgro is recalling Clip Clop infant activity rattle toys because the abacus ring can dislodge and release small beads, posing a choking hazard to small children.

    Product
    Clip Clop Infant Activity Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2021·2021-04-14

    Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

    Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

    Product
    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1379-2021·2021-04-14

    Howmedica Recalls Specialty Triathlon TS Trial Cutting Guides Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling Specialty Triathlon TS Trial Cutting Guides because the posterior condyle may fracture during transport or surgery.

    Product
    Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighCPSC·21109·2021-04-14

    Battat Recalls Firefly Frank Infant Teethers Due to Choking Hazard

    Battat is recalling B. toys Firefly Frank infant teethers sold at Target because plastic wings can detach, posing a choking hazard to young children.

    Product
    B. toys Firefly Frank Infant Teethers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2021·2021-04-14

    ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits

    ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.

    Product
    Regard, Item Number 830067009, custom cardiovascular procedure kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2021·2021-04-14

    Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch

    Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.

    Product
    Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighCPSC·21110·2021-04-14

    Audio-Technica Recalls Wireless Headphone Charging Cases Due to Fire Hazard

    Audio-Technica is recalling charging cases for ATH-CK3TW wireless headphones because they can overheat and pose a fire hazard. No injuries have been reported.

    Product
    Charging Cases Sold with Audio-Technica Wireless Headphones, Model ATH-CK3TW
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2021·2021-04-14

    BD BBL Martin-Lewis Agar Recalled for Misformulation and Fungal Growth

    Becton Dickinson is recalling BD BBL Martin-Lewis Agar due to misformulation causing heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0388-2021·2021-04-14

    B&G Sweet Heat Pepper Dip Recalled for Undeclared Milk Allergen

    B&G Sweet Heat Peppers is recalling 43 cases of Sweet Heat Pepper Dip because the label fails to declare milk, despite containing cream cheese and sour cream.

    Product
    B&G Sweet Heat Pepper Dip, Ready To Eat, Refrigerated, packaged in 10 oz, semi-rigid plastic container. UPC 7 42832 07566 4. Product label is read in parts: "***SWEET HEAT PEPPER DIP ***Ingredients: Cream Cheese, Sour Cream, Jalapenos, Sugar, Apple Cider Vinegar, Granulated…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1369-2021·2021-04-14

    Hologic Recalls Panther Fusion Tube Trays Due to Potential Leakage

    Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.

    Product
    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2021·2021-04-14

    Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display

    Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.

    Product
    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states

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