The Recall Desk

Archive

February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical
14
Severe
237
High
233
Moderate
176
Low
6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

Which agencies issued them

201–300 of 666

  • HighFDA (Devices)·Z-0593-2022·2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects

    GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2022·2022-02-16

    Baxter PD Transfer Sets may leak or crack from common cleaning products

    Certain cleaning products can damage Baxter MiniCap Extended Life PD Transfer Sets, causing them to leak or crack. Baxter is recalling approximately 61,290 units sold worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0608-2022·2022-02-16

    GE Healthcare MRI systems recalled over improper cryogen ventilation

    GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2022·2022-02-16

    MIC Percutaneous Endoscopic Gastrostomy Kits Recalled for Oversized Retention Bolster

    Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.

    Product
    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2022·2022-02-16

    QC Control Materials KWIK-STIK AST-GP Produce Incorrect Test Results

    Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.

    Product
    QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2022·2022-02-16

    Baxter CAPD Transfer Sets May Leak if Cleaned with Certain Chemicals

    Baxter Healthcare is recalling CAPD MiniCap Transfer Set II units worldwide because certain cleaning products containing chemicals like hydrogen peroxide, bleach, and solvents may cause the sets to leak or crack.

    Product
    Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0800-2022·2022-02-16

    MCT Oil Powder Recalled for Undeclared Milk Allergen

    Simply Goodfats Creamy MCT Vanilla MCT Oil Powder is recalled due to undeclared milk allergen. The recall affects approximately 1,647 units distributed online in the US.

    Product
    Simply Goodfats Creamy MCT Vanilla MCT Oil Powder 10.5 OZ packaged White HDPE Plastic. UPC Code: 857826008648 Expiration dates: 8/31/2021 8/31/2022 2/28/2022
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0566-2022·2022-02-16

    Avanos MIC Percutaneous Gastrostomy Kit Recalled for Bolster Sizing Defect

    Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy PEG Kit because the external retention bolster may be larger than the tube, creating a risk of improper fit and potential device failure.

    Product
    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0730-2022·2022-02-16

    Amy's Vegan Rice Mac & Cheese Recall: Undeclared Milk Allergen

    Amy's Kitchen is recalling its Vegan Organic Rice Mac & Cheese due to undeclared milk detected during testing. The product is labeled dairy-free, posing a risk to consumers with milk allergies.

    Product
    Amy's Vegan Organic Rice Mac & Cheese; frozen; 8 oz. (227 g) individually packaged serving; in trays with plastic overwrap, inside preprinted cardboard boxes; UPC 04227200432; Amy's Kitchen, Inc., P.O.Box 7129, Petaluma, CA 94955 8 or 12 retail units per case; Organic Gluten Free
    Category
    Food
    Distribution
    33 states
  • HighNHTSA·22V088000·2022-02-16

    2022 Lincoln Aviator Fuel Filler Tube May Detach During Crash

    Ford is recalling certain 2022 Lincoln Aviator vehicles because the fuel filler tube may detach during a crash, creating a fuel leak and fire risk. Free repairs are available from Ford dealers.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2022·2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2022·2022-02-16

    Arterial Line Kits recalled due to guidewire-needle incompatibility

    Argon Medical Devices is recalling Arterial Line Kits because the included guidewires don't fit through the kit's needles. This could cause procedure delays and minor blood loss.

    Product
    1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2022·2022-02-16

    GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect

    GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22080·2022-02-16

    Esme Children's Sleepwear Garments Fail Flammability Standards

    Esme is recalling about 3,600 children's sleepwear garments because they fail federal flammability standards and pose a burn risk. Consumers should stop using them immediately and contact Esme for a free replacement or refund.

    Product
    Children's Sleepwear Garments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2022·2022-02-16

    Baxter PD Transfer Set Recall: Risk of Leaking or Cracking

    Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0594-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

    GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2022·2022-02-16

    GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall

    GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Cryogen Ventilation Issue

    GE Healthcare is recalling 17,228 SIGNA Artist MRI systems due to a potential defect in the cryogen ventilation system that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0799-2022·2022-02-16

    Simply Goodfats MCT Oil Powder Recalled for Undeclared Milk Allergen

    Simply Goodfats Creamy MCT Unflavored MCT Oil Powder is recalled due to undeclared milk allergen. The product was distributed to online customers in the US.

    Product
    Simply Goodfats Creamy MCT Unflavored MCT Oil Powder 10.5 OZ. Packaged White HDPE Plastic. UPC Code: 857826008594 Expiration dates: 11/30/2021 2/28/2022 7/31/2021
    Category
    Food
    Distribution
    0 states
  • HighCPSC·22081·2022-02-16

    American Landmaster Utility Vehicles Recalled for Steering Shaft Separation

    American Landmaster has recalled about 1,050 utility vehicles (EV, L3, L4, L5, L5W, and L7 models) because the steering shaft can separate from its joint, causing loss of control and crash hazards. Seven steering shaft separations have been reported with no injuries yet.

    Product
    American Landmaster EV, L3, L4, L5, L5W and L7 Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2022·2022-02-16

    Knee Replacement Component Recalled for Adhesive Residue Risk

    DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.

    Product
    ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0637-2022·2022-02-16

    Natural Way Cheese 3 Pepper Cheese Curds recalled for improper milk storage

    Natural Way Cheese is recalling 3 Pepper Cheese Curds (12oz bags) distributed in Michigan and Indiana due to milk stored in a holding tank for more than 72 hours, exceeding required cleaning intervals.

    Product
    Natural Way Cheese 3 Pepper Cheese Curds, retail 12oz plastic bag UPC 8 10056 75020 6, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0579-2022·2022-02-16

    Baxter CAPD Transfer Sets may crack or leak when exposed to cleaning chemicals

    Baxter CAPD MiniCap Transfer Set II units may leak or crack when cleaned with chemicals including bleach, hydrogen peroxide, or solvents. The recall affects 8,928 units distributed worldwide.

    Product
    Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V087000·2022-02-16

    Ford F-250 and F-350 Driveshaft Fracture Risk From Loose Insulators

    Ford is recalling 2017–2022 F-250 and F-350 Super Duty trucks. Underbody insulators may loosen and damage the aluminum driveshaft, potentially causing loss of drive power or vehicle control.

    Product
    FORD — FORD F-250 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2022·2022-02-16

    GE Healthcare MRI systems recalled for cryogenic ventilation defect

    GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V086000·2022-02-16

    2019 Volkswagen Atlas: Missing GVWR Label on Side-Step Models

    Volkswagen is recalling certain 2018-2021 Atlas and Atlas Cross Sport vehicles equipped with side steps due to a missing GVWR label that reflects the additional weight, increasing overloading risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0639-2022·2022-02-16

    Cheese Curds Recalled for Improper Milk Tank Sanitation

    Natural Way Cheese hickory smoke flavor cheese curds are recalled because milk used in the product was stored in a holding tank beyond the required 72-hour cleaning interval. The recall affects products distributed in Michigan and Indiana.

    Product
    Natural Way Cheese Hickory Smoke Flavor Cheese Curds, retail 12oz plastic bag UPC 8 10056 75017 6, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0690-2022·2022-02-16

    Dole Chopped Teriyaki Pineapple Kit recalled for potential Listeria contamination

    Dole Fresh Vegetables is recalling its 9.8oz Chopped Teriyaki Pineapple Kit due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide with specific Best if Used By dates.

    Product
    Dole 9.8oz Chopped Teriyaki Pineapple Kit Product UPC 071430001004
    Category
    Food
    Distribution
    36 states
  • HighFDA (Food)·F-0739-2022·2022-02-16

    Lily's Peppermint Flavor Baking Chips Recalled for Undeclared Soy Allergen

    Lily's Sweets is recalling 7 oz. pouches of Peppermint Flavor Baking Chips because they contain undeclared soy lecithin, a common allergen. The product was distributed to 22 U.S. states.

    Product
    Lily s Peppermint Flavor Baking Chips, 7 oz. Pouch
    Category
    Food
    Distribution
    22 states
  • HighNHTSA·22V083000·2022-02-16

    2021-2022 Ford Mustang Front Passenger Knee Air Bag Weld Defect

    Ford is recalling 2021-2022 Mustang vehicles due to insufficient welds on the front passenger knee air bag, which could deploy improperly and increase injury risk during crashes. Affected owners should contact dealers for a free replacement.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2022·2022-02-16

    GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation

    GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V084000·2022-02-16

    Audi Recalls 2022 E-Tron GT for Rear Seat Belt Wiring Issue

    Audi is recalling 2022 E-Tron GT vehicles because the center seat belt wiring harness may block access to child seat anchors, preventing proper securing.

    Product
    AUDI — AUDI E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2022·2022-02-16

    Orthopedic knee replacement component recalled for adhesive residue contamination

    DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.

    Product
    ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0634-2022·2022-02-16

    Natural Way Cheese Horseradish Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Horseradish Cheese Curds because the milk used was stored in a tank beyond the required 72-hour cleaning interval, creating risk of bacterial contamination.

    Product
    Natural Way Cheese Horseradish Cheese Curds, retail 12oz plastic bag UPC 8 10056 75106 7, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·20V567000·2022-02-16

    2017-2021 Freightliner Cascadia Brake Lights May Remain Illuminated

    Daimler Trucks North America is recalling 2017-2021 Freightliner Cascadia trucks because brake lights may remain illuminated after braking. This increases crash risk by making drivers unaware of actual braking.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2022·2022-02-16

    GE Healthcare MRI systems recalled for cryogen ventilation defect

    GE Healthcare is recalling certain MRI systems because the cryogen ventilation system does not meet venting requirements. The defect could affect safe operation of the MRI magnet.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibran
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2022·2022-02-16

    BD Veritor Plus Analyzer may overheat when using unauthorized power adapter

    BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.

    Product
    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2022·2022-02-16

    GE Healthcare Optima MR430s MRI systems have potential cryogenic ventilation defect

    GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2022·2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling SIGNA Premier MRI systems due to a cryogen ventilation system that does not meet venting requirements. Approximately 17,228 affected devices were distributed worldwide.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V081000·2022-02-16

    Lamborghini Recalls Huracan Models Due to Missing Headlight Adjustment Caps

    Lamborghini is recalling 2015-2020 Huracan vehicles because missing caps on headlight adjustment screws can lead to improper alignment, reducing visibility and increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI HURACAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2022·2022-02-16

    Baxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk

    Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0562-2022·2022-02-16

    Novalung Sensor Box Communication Failure May Disable Flow Measurement

    The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.

    Product
    Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2022·2022-02-16

    Quality Control Kit for Antibiotic Susceptibility Testing Returning Incorrect Results

    Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2022·2022-02-16

    R82 by ETAC Push Brace for High-Low recalled due to cracking hazard

    The R82 by ETAC Push Brace for High-Low is being recalled because the chrome surface can crack during use, potentially cutting users. Approximately 396 units manufactured between August and October 2021 are affected.

    Product
    R82 by ETAC Push Brace for High-Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2022·2022-02-16

    Baxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0586-2022·2022-02-16

    Diagnostic Control Microorganism Recalled for Incorrect Test Results

    Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.

    Product
    LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect

    GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2022·2022-02-16

    CURAD Reusable Gel Hot/Cold Pack Contains Undisclosed Natural Rubber Latex

    Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.

    Product
    CURAD REUSABLE GEL HOT/COLD PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0601-2022·2022-02-16

    GE Healthcare MRI Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2022·2022-02-16

    Baxter PD Transfer Sets Recalled Due to Chemical Damage Risk

    Baxter Healthcare is recalling approximately 58,194 units of its MiniCap Extended Life PD Transfer Sets distributed worldwide because certain cleaning products may damage the sets, causing leaking or cracking.

    Product
    Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0611-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation

    GE Healthcare has recalled 17,228 MRI systems because the cryogenic ventilation system does not meet safety requirements. Systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0638-2022·2022-02-16

    Natural Way Cheese Bacon Cheddar Cheese Curds recalled for improper storage

    Natural Way Cheese Bacon Cheddar Cheese Curds are being recalled in Michigan and Indiana because milk used in production was stored in a holding tank exceeding the required 72-hour cleaning interval.

    Product
    Natural Way Cheese Bacon Cheddar Cheese Curds, retail 12oz plastic bag UPC 8 10056 75175 3, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0616-2022·2022-02-16

    GE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2022·2022-02-16

    LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination

    Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.

    Product
    LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0632-2022·2022-02-16

    Natural Way Cheese Chive Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese Chive Cheese Curds (12oz bags) distributed in Michigan and Indiana are recalled because milk used was stored beyond the required 72-hour tank cleaning interval, creating a risk of bacterial growth.

    Product
    Natural Way Cheese Chive Cheese Curds, retail 12oz plastic bag UPC 8 10056 75107 4, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·22E009000·2022-02-16

    Fuel Helmets Recalls SH-WS001 Motorcycle Helmets for Impact Protection Defect

    Fuel Helmets is recalling specific SH-WS001 motorcycle helmets that may not adequately protect the wearer in a crash. Owners will receive a credit to replace or reimburse the helmet.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2022·2022-02-16

    GE Healthcare MR superconducting magnets recalled due to cryogen ventilation system defect

    GE Healthcare has recalled 17,228 MR superconducting magnets used in nuclear magnetic resonance imaging systems because the cryogen ventilation system does not meet required venting standards. The recall affects devices distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0641-2022·2022-02-16

    Natural Way Cheese Sweet Basil Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Sweet Basil Cheese Curds because the milk used was stored in a holding tank for more than 72 hours, exceeding required cleaning intervals.

    Product
    Natural Way Cheese Sweet Basil Cheese Curds, retail 12oz plastic bag UPC 8 10056 75015 2, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0607-2022·2022-02-16

    GE Healthcare SIGNA MR Systems cryogenic ventilation system defect recall

    GE Healthcare recalled approximately 17,228 SIGNA MR magnetic resonance imaging systems because the cryogenic ventilation systems may not meet proper venting requirements. The defect could create potential safety hazards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2022·2022-02-16

    GE Healthcare MR Magnets Cryogenic Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MR superconducting magnet systems because the cryogenic ventilation system may not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2022·2022-02-16

    Baxter MiniCap PD Transfer Sets Recalled Due to Damage from Cleaning Products

    Baxter Healthcare is recalling 344,190 units of MiniCap Extended Life PD Transfer Sets worldwide because certain cleaning products may cause the sets to leak or crack, potentially affecting patient dialysis treatment.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0606-2022·2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

    GE Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2022·2022-02-16

    Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications

    Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.

    Product
    QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2022·2022-02-16

    GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems

    GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2022·2022-02-16

    Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations

    ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.

    Product
    Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0725-2022·2022-02-16

    Caffeine vitamin supplement tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.

    Product
    Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0640-2022·2022-02-16

    Natural Way Cheese Dill Cheese Curds Recalled for Improper Milk Storage

    Natural Way Cheese is recalling Dill Cheese Curds because milk was stored in a holding tank longer than the required 72-hour cleaning interval. The improper storage creates a potential food safety risk.

    Product
    Natural Way Cheese Dill Cheese Curds, retail 12oz plastic bag UPC 8 10056 75019 0, 12 retail units per wholesale case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0542-2022·2022-02-16

    Spearmint Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.

    Product
    Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0567-2022·2022-02-16

    Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits

    A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0723-2022·2022-02-16

    Caffeine dietary supplement recalled due to manufacturing practice deviations

    ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.

    Product
    Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateCPSC·22084·2022-02-16

    Scarves Recalled for Flammability Standard Violation and Burn Risk

    In-Things Corporation is recalling about 200 "Sparkle Sheer Social Wrap" scarves sold online because they fail to meet federal flammability standards for textiles, posing a burn injury risk.

    Product
    Scarves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22085·2022-02-16

    Anecdote Autumn Glass Candles recalled for fire and laceration hazards

    Anecdote Candles is recalling approximately 19,380 Autumn Glass Candles sold at Anthropologie because the double-wick candles can produce higher-than-normal flames, causing the glass container to break and posing fire and laceration hazards.

    Product
    Anecdote Autumn Glass Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0721-2022·2022-02-16

    Caffeine and vitamin dietary supplement tablets recalled for manufacturing practice deviations

    ULTRAtab Laboratories recalls Ephrine Plus dietary supplement tablets due to manufacturing practice deviations. The recall involves 4,250,842 tablets distributed to bulk distributors in New York and Florida.

    Product
    Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0548-2022·2022-02-16

    Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations

    ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.

    Product
    APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0582-2022·2022-02-16

    Medical device reference standard contaminated with bacterial species

    Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

    Product
    KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0727-2022·2022-02-16

    Dietary supplement melatonin recall due to manufacturing deviations

    ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.

    Product
    Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0531-2022·2022-02-16

    Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.

    Product
    APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0728-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.

    Product
    Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0637-2022·2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0525-2022·2022-02-16

    Zee Cold Tabs Recalled for CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0546-2022·2022-02-16

    Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container

    ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.

    Product
    Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0537-2022·2022-02-16

    APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations

    ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.

    Product
    APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0523-2022·2022-02-16

    3-Component Cold Tabs Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0729-2022·2022-02-16

    Melatonin supplement MidNite Tablet recalled for manufacturing deviations

    ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.

    Product
    MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0538-2022·2022-02-16

    HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.

    Product
    HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0554-2022·2022-02-16

    DBI Magnums Caffeine Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.

    Product
    DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0722-2022·2022-02-16

    Electrolyte Tablets Recalled by ULTRAtab Laboratories Due to Manufacturing Deviations

    ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0539-2022·2022-02-16

    Peppermint Antacid Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0726-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.

    Product
    Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0544-2022·2022-02-16

    Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.

    Product
    Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0551-2022·2022-02-16

    Back Relief II Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.

    Product
    Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0543-2022·2022-02-16

    Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0621-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0553-2022·2022-02-16

    Drug Recall: Coated Back Relief Tablet CGMP Deviations

    ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.

    Product
    Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0529-2022·2022-02-16

    APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall

    ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.

    Product
    APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0724-2022·2022-02-16

    Caffeine vitamin supplement recalled for manufacturing process deviations

    ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states

Looking for a different month? Back to 2022.