The Recall Desk

Archive

April 2021 recalls

449 recalls were announced in April 2021.

What the numbers show

Critical
28
Severe
96
High
217
Moderate
95
Low
13

Of the 449 recalls this month scored against our rubric, 6% are Critical, 21% are Severe.

1–100 of 449

  • SevereNHTSA·21E038000·2021-04-30

    Mando Recalls ABS Modules Due to Electrical Short Circuit Fire Risk

    Mando America Corporation is recalling specific Anti-lock Brake System (ABS) modules that may malfunction and short circuit, increasing the risk of an engine compartment fire.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E039000·2021-04-30

    Mando Recalls ABS Modules for Brake Fluid Leak and Fire Risk

    Mando America Corporation is recalling certain Anti-lock Brake System (ABS) modules that may leak brake fluid and cause a short circuit, increasing the risk of an engine compartment fire.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V304000·2021-04-30

    KTM Recalls 790 Adventure Motorcycles Due to Weak Front Brake Spring

    KTM is recalling 2019-2020 790 Adventure models because a weak front brake spring may reduce braking functionality, increasing the risk of a crash.

    Product
    KTM — KTM 790 ADVENTURE, 790 ADVENTURE R, 790 ADVENTURE R RALLY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V306000·2021-04-30

    Tiffin Bus and Phaeton motorhomes recalled for fuel rail leakage and fire risk

    Tiffin Motorhomes is recalling 2017-2021 Bus and Phaeton vehicles due to fuel rail assembly defects that may leak, posing a fire risk. Owners should contact Tiffin customer service at 1-256-356-8661 for a free inspection.

    Product
    TIFFIN — TIFFIN BUS, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V305000·2021-04-30

    NorthStar Ambulance Recall for Display Lockup Hazard

    Braun Northwest is recalling 2013-2020 NorthStar Ambulances because LCD displays may lock up, potentially delaying emergency efforts.

    Product
    NORTHSTAR — NORTHSTAR AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E037000·2021-04-29

    Full Vision Recalls Rogers Brothers Rear Impact Guards Due to Weak Steel

    Full Vision is recalling Rogers Brothers Rear Impact Guards because the steel may not meet specifications, potentially reducing strength and increasing injury risk in crashes.

    Product
    STRUCTURE:BODY:BUMPERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21740·2021-04-29

    Modernist Pantry Recalls Sodium Hydroxide for Packaging and Labeling Defects

    Modernist Pantry is recalling Kitchen Alchemy Sodium Hydroxide products because the packaging is not child-resistant and labels violate federal hazardous substance requirements.

    Product
    Modernist Pantry Kitchen Alchemy Sodium Hydroxide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0481-2021·2021-04-28

    Real Alkalized Water Recalled Due to Acute Liver Failure Reports

    Real Water, Inc. is recalling Real Alkalized Water in various bottle sizes after the FDA was notified of cases of acute liver failure following consumption.

    Product
    Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0482-2021·2021-04-28

    Real Alkalized Water Concentrate Recalled Due to Liver Failure Reports

    Real Water, Inc. is recalling Real Alkalized Water concentrate after FDA was notified of cases of acute liver failure following consumption.

    Product
    Real Alkalized Water, concentrate. 4 oz. glass bottle . Drinkrealwater.com
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2021·2021-04-28

    Teligent Pharma Recalls Flurandrenolide Ointment Due to Impurity Failures

    Teligent Pharma is recalling 3,432 tubes of Flurandrenolide Ointment 0.05% because the product failed impurity and degradation specifications.

    Product
    Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1468-2021·2021-04-28

    Trinity Sterile Recalls Midline Catheter Dressing Change Kits Due to Seal Defects

    Trinity Sterile, Inc. is recalling 2,970 Midline Catheter Dressing Change Kits with Statlock because evidence of foreign material in the seal caused improper sealing and compromised sterility.

    Product
    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2021·2021-04-28

    Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

    Product
    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2021·2021-04-28

    Smiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex pressure injector lines and related components due to insufficient or incomplete welds.

    Product
    Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1473-2021·2021-04-28

    Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2021·2021-04-28

    BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion

    BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0455-2021·2021-04-28

    Snowville Creamery Whipping Cream Recalled for Improper Pasteurization

    Snowville Creamery is recalling 297 units of 64oz Whipping Cream because the product does not meet regulatory standards for proper pasteurization.

    Product
    Snowville Creamery Whipping Cream 64oz Paperboard Carton Sold as individual Units
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1479-2021·2021-04-28

    Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.

    Product
    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0472-2021·2021-04-28

    Quirch Foods Recalls Frozen Yellowfin Tuna Portions Due to Histamines

    Quirch Foods is recalling 55 cases of frozen yellowfin tuna portions due to fish decomposition and histamines. The product was distributed domestically in Puerto Rico.

    Product
    Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1467-2021·2021-04-28

    AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

    AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

    Product
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0435-2021·2021-04-28

    Glutenull Goji Berries & Chocolate Cookies Recalled for Undeclared Milk

    Amra Services Ltd. is recalling Glutenull Goji Berries & Chocolate Cookies in Oregon and Washington due to undeclared milk.

    Product
    Glutenull Goji Berries & Chocolate Cookies, packaged in a clear plastic clamshell container, net wt. 11 oz. (320g). UPC 628451529132. The label also states "Non-GMO * Gluten Free Certified * Vegan * GluteNull Bakery Port Coquitlam, BC V3C 6P8 ***".
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1474-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk

    Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion

    BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21118·2021-04-28

    UST Recalls LifeSeasons Iron Supplement Due to Child-Resistant Packaging Failure

    UST Mfg. LLC. is recalling LifeSeasons Blood Nourish-R iron supplements because the bottles do not meet child-resistant packaging requirements, posing a poisoning risk to young children.

    Product
    LifeSeasons Blood Nourish-R Iron Supplement
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2021·2021-04-28

    Biotronik Iperia 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 1,652 Iperia 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2021·2021-04-28

    Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    Left Heart Kit, Model Number M20268. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2021·2021-04-28

    Smiths Medical Recalls Stopcock Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific stopcock rotator components used in cardiac kits due to insufficient or incomplete welds.

    Product
    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 2,881 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion.

    Product
    BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 670 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 702 Inventa 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0437-2021·2021-04-28

    Avanti Recalls 365 Whole Foods Market Farm Raised Cooked Shrimp

    Avanti Frozen Foods is recalling 365 Whole Foods Market Farm Raised Cooked Shrimp because uncooked shrimp were inadvertently packaged as cooked.

    Product
    365 Whole Foods Market Farm Raised Cooked Shrimp 2 lbs/Ready- to - Serve Tail-On/Peeled & Deveined/41-55 Shrimp/lb NET WT 32 OZ (2 LB) 907g packaged in clear plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 3,832 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2021·2021-04-28

    Biotronik ILIVIA 7 ICD Recall for Premature Battery Depletion

    Biotronik is recalling 3,497 ILIVIA 7 implantable cardioverter defibrillators due to a potential for premature battery depletion. The recall covers units distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2021·2021-04-28

    Siemens Sensis Systems Recalled for Windows Service Permission Vulnerability

    Siemens Medical Solutions is recalling Sensis and Sensis Vibe Hemo systems due to Windows Service Permission configuration risks that could expose sensitive information or allow data manipulation.

    Product
    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 1100764
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2021·2021-04-28

    Biotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion

    Biotronik is recalling 17 Intica Neo 7 VR-T DX DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2021·2021-04-28

    Biotronik Intica Neo 7 HF-T Defibrillators Recalled for Battery Depletion

    Biotronik is recalling eight Intica Neo 7 HF-T implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2021·2021-04-28

    Smiths Medical Recalls LogiCal Monitoring Sets Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Monitoring Sets and related components due to insufficient or incomplete welds.

    Product
    LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2021·2021-04-28

    Biotronik Ilestro 7 DR-T Recall for Premature Battery Depletion

    Biotronik is recalling Ilestro 7 DR-T implantable defibrillators due to a potential for premature battery depletion. Affected devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2021·2021-04-28

    Mountain West Mothers' Milk Bank Recalls Pasteurized Donor Human Milk

    Mountain West Mothers' Milk Bank is recalling pasteurized donor human milk bottles due to a foreign object found in a bottle. The affected milk was distributed in Salt Lake County and Utah County, Utah.

    Product
    Mountain West Mothers' Milk Bank - Pasteurized Donor Human Milk, 3 fluid ounce BPA free plastic bottles, embossed with "Donor Human Milk" and graduation marks on the front side Unique identifier label which includes distributing Milk Bank Code (MWMMB), Batch ID, Unique Bottle num
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0451-2021·2021-04-28

    Trader Joe's White Corn Tortilla Chips Recalled for Undeclared Milk

    Snak King Corporation is recalling Trader Joe's Restaurant Style White Corn Tortilla Chips because they may contain undeclared milk.

    Product
    Trader Joe's Restaurant Style White Corn Tortilla Chips; Net Wt. 9 oz. (255g)
    Category
    Food
    Distribution
    23 states
  • HighNHTSA·21V300000·2021-04-28

    Blue Bird Recalls 2018-2021 School Buses for Power Steering Defect

    Blue Bird is recalling 2018-2021 Vision and All American school buses because an electrical issue may cause a loss of power steering, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, ALL AMERICAN, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0454-2021·2021-04-28

    Reser's Macaroni Salad Recalled for Undeclared Wheat and Egg Allergens

    Reser's Fine Foods is recalling Freshness Guaranteed Macaroni Salad Amish because the bottom label incorrectly identifies the product as Red Potatoes or Baked Beans, failing to declare wheat and egg allergens.

    Product
    Freshness Guaranteed Macaroni Salad Amish, item # 579284, refrigerated, packaged in a clear cup with clear snap on lid, net wt. 32 oz. UPC 0 78742 13235 8. Each master case containing 6/32 oz. packages. Distributed by: Walmart Inc, Bentonville, AR. The CORRECT label is read i
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1471-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2021·2021-04-28

    BIOTRONIK Ilestro 7 DR-T ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling Ilestro 7 DR-T implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0452-2021·2021-04-28

    Rise Baking Company Recalls Vanilla Bean Waterfall Cakes for Undeclared Hazelnut

    Rise Baking Company is recalling Dawn Food Products 7 1/2 Layer Vanilla Bean Waterfall Cakes because the label fails to list hazelnut as an ingredient.

    Product
    Dawn Food Products, 7 2 Layer Vanilla Bean Waterfall Cake, 35 oz., cake is placed on a cardboard plate which is then placed on a plastic plate and closed in a plastic dome, 6 cakes per case , Keep frozen for storage. Store refrigerated or ambient for sale and use.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0453-2021·2021-04-28

    Rise Baking Recalls Dawn Cookies and Creme Cakes for Undeclared Hazelnut

    Rise Baking Company is recalling Dawn 3 Layer Cookies and Creme Cakes because the label fails to list hazelnut as an ingredient.

    Product
    Dawn Food Products,8 3 Layer Cookies and Creme Cake , 35 oz., cake is placed on a cardboard plate which is then placed on a plastic plate and closed in a plastic dome, 6 cakes per case , Keep frozen for storage. Store refrigerated or ambient for sale and use.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1458-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 779 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.

    Product
    ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21117·2021-04-28

    Sauder Woodworking Recalls Counter-Height Bar Stools Due to Fall Hazard

    Sauder Woodworking is recalling about 3,100 counter-height bar stools because the legs can become unstable, posing a fall hazard. No injuries have been reported.

    Product
    Sauder and Aliesha-May Counter-height bar stools (two-piece sets)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,000 Ilestro 7 VR-T implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V299000·2021-04-28

    Suzuki Recalls 2019-2020 UH200 Motorcycles Due to Speedometer Defect

    Suzuki is recalling 2019-2020 UH200 motorcycles because corroded speedometer resistors may cause the speedometer and odometer to stop working, increasing crash risk.

    Product
    SUZUKI — SUZUKI UH200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V298000·2021-04-28

    2021 BMW 330E Seat Belt Buckle Assembly Bolt Not Properly Secured

    BMW is recalling certain 2021 330E, 330i, M340i, and M3 vehicles due to an undertightened bolt on the front seat belt buckle assembly. The defect may prevent proper occupant restraint, increasing injury risk.

    Product
    BMW — BMW M340I, 330I, 330E, M3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21119·2021-04-28

    Pentair Recalls StaRite and Mastertemp Pool Heaters Due to Fire Hazard

    Pentair Water Pool and Spa is recalling about 4,700 StaRite and Mastertemp pool heaters because a connection can leak a combustible air-gas mixture, posing a fire hazard.

    Product
    StaRite and Mastertemp pool heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2021·2021-04-28

    Biotronik Iforia 7 ICDs Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,176 Iforia 7 implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2021·2021-04-28

    Smiths Medical Recalls Tubing Components Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of tubing components for blood-pressure transducers due to insufficient or incomplete welds.

    Product
    Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2021·2021-04-28

    Biotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion

    Biotronik is recalling 74 ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 499 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2021·2021-04-28

    Siemens BCS XP System Recalled for Potential Emicizumab Carryover

    Siemens Healthcare Diagnostics is recalling BCS XP Systems due to a potential risk of Emicizumab carryover on patient samples.

    Product
    BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2021·2021-04-28

    AngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns

    AngioDynamics is recalling specific lots of Smart Port CT-Implantable Port kits due to potential compromised sterility. The recall affects 267 kits distributed nationwide.

    Product
    Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and pow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion

    Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 658 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V302000·2021-04-28

    2021 Hyundai Elantra seat back recliner frame welding defect

    Hyundai is recalling certain 2021 Elantra vehicles because the driver and front passenger seat back recliners may have been improperly welded and could separate during a crash, increasing injury risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V301000·2021-04-28

    Multiple Hyundai models recalled for engine piston ring defect

    Hyundai is recalling 2019–2021 Kona, Elantra, and Veloster models with 2.0L engines. Improperly heat-treated piston rings may cause engine damage, stalling, and fire risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA, VELOSTER, KONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Tubing Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex high pressure tubing and components due to insufficient or incomplete welds.

    Product
    HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2021·2021-04-28

    Aftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors

    Pacific Medical Group is recalling 2,452 aftermarket Alaris infusion pump front bezels installed between July 2020 and February 2021. The bezel posts may crack or separate, potentially causing infusion errors.

    Product
    Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1439-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes misidentify the size of the contained device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0446-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Dyes and Unapproved Colorant

    USA LANKA INC is recalling Motha Jelly Crystals because the product contains undeclared FD&C yellow #5 and blue #1, as well as the unapproved dye carmoisine.

    Product
    Motha Jelly Crystals - Mixed Fruit Flavoured Jelly, Net Wt. 100g,
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1485-2021·2021-04-28

    Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0434-2021·2021-04-28

    Tropicana Recalls KeVita Cucumber Rosemary Kombucha Due to Mislabeling

    Tropicana Products, Inc. is recalling 5,479 cases of KeVita Cucumber Rosemary kombucha due to mislabeling of the bottled product inside the case.

    Product
    KeVita Cucumber Rosemary (primary package), 15.2 oz., glass bottles, 6 packages per case, refrigerated storage
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1431-2021·2021-04-28

    Bard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects

    C.R. Bard is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters because the catheter tip was cut off and the packaging was not fully sealed.

    Product
    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1484-2021·2021-04-28

    Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0444-2021·2021-04-28

    Thai Home Mussaman Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling 105 cases of Thai Home brand Mussaman Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Mussaman Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004047 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 S
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0449-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Red Dye

    USA Lanka Inc. is recalling Motha Jelly Crystals Strawberry Flavoured Jelly because it contains undeclared FD&C Red #40.

    Product
    Motha Jelly Crystals Strawberry Flavoured Jelly , Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0450-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared FD&C Yellow #6

    USA LANKA INC is recalling Motha Jelly Crystals because the product contains undeclared FD&C Yellow #6, a food dye.

    Product
    Motha Jelly Crystals - Orange Flavoured Jelly, Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1483-2021·2021-04-28

    Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0448-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Artificial Dyes

    USA LANKA INC is recalling Motha Jelly Crystals because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Motha Jelly Crystals - Mango Flavoured Jelly, Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0440-2021·2021-04-28

    Thai Home Green Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Green Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Green Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004023. Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0443-2021·2021-04-28

    Thai Home Panang Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Panang Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Panang Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 0861608000485 Manufactured by: Jansala & Foods LLC 1640 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1482-2021·2021-04-28

    Welch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 99 ELI 280 Electrocardiographs because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1432-2021·2021-04-28

    Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors

    Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.

    Product
    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2021·2021-04-28

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects

    Noven Pharmaceuticals is recalling Minivelle estradiol transdermal patches because the adhesive may not stick well to the skin.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1433-2021·2021-04-28

    Boston Scientific AMS 700 Penile Prosthesis Reservoirs Recalled for Mislabeling

    Boston Scientific is recalling 23 AMS 700 penile prosthesis reservoirs because they were incorrectly labeled as a different model type.

    Product
    The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1436-2021·2021-04-28

    Stryker DirectInject Bone Cement Recalled Due to Injection Failure

    Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected from the syringe into the target location.

    Product
    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2021·2021-04-28

    Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns

    Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.

    Product
    Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Recall

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0441-2021·2021-04-28

    Thai Home Red Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Red Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Red Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004016 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE Laf
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0445-2021·2021-04-28

    Thai Home Satay Peanut Sauce Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Satay Peanut Sauce due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Satay Peanut Sauce packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004078 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2021.