The Recall Desk

Archive

February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical
14
Severe
241
High
229
Moderate
176
Low
6

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

Which agencies issued them

301–400 of 666

  • ModerateFDA (Food)·F-0633-2022·2022-02-16

    Cheese Curds Recalled for Improper Milk Storage in Michigan and Indiana

    Natural Way Cheese Marble Cheese Curds are being recalled because the milk used was stored beyond the required 72-hour tank cleaning interval, creating potential food safety risk.

    Product
    Natural Way Cheese Marble Cheese Curds, retail 12oz plastic bag UPC 8 10056 75022 0, 12 retail units per wholesale case, and sold in 10lbs wholesale plastic bag as well
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0549-2022·2022-02-16

    Normed Fem Tablet Recalled Due to CGMP Deviations

    ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.

    Product
    Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
    Category
    Drug
    Distribution
    0 states
  • 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-0545-2022·2022-02-16

    Phenylephrine HCl 5 mg Tablet Recall Due to CGMP Deviations

    ULTRAtab Laboratories is recalling Phenylephrine HCl 5 mg tablets in bulk containers due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 4.5 million tablets distributed to three distributors.

    Product
    Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
    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
  • 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
  • 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 (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 (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 (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-0533-2022·2022-02-16

    Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets

    ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.

    Product
    Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
    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-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 (Drugs)·D-0536-2022·2022-02-16

    Acetaminophen 500 mg tablets recalled for CGMP deviations

    ULTRAtab Laboratories is recalling approximately 6.2 million acetaminophen 500 mg tablets due to current good manufacturing practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0552-2022·2022-02-16

    Legatrin Acetaminophen and Diphenhydramine Tablets Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets to three distributors.

    Product
    Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0524-2022·2022-02-16

    Cold Tabs Drug Recalled for CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed to three distributors.

    Product
    4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
    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 (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
  • LowFDA (Devices)·Z-0581-2022·2022-02-16

    Medical device lot number misprinted on packaging

    Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.

    Product
    KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V080000·2022-02-15

    Land Rover Recalls 2020 Range Rover Evoque for SRS Warning Light Software Defect

    Jaguar Land Rover is recalling 2020 Range Rover Evoque vehicles because incorrect software may cause the airbag warning light to malfunction, potentially masking actual system failures.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E007000·2022-02-14

    Weldon recalls rear combination lamps with incorrect white backup lights

    Weldon is recalling specific rear combination lamps because the LED backup lights are the wrong color, failing federal safety standards and potentially affecting vehicle visibility.

    Product
    EXTERIOR LIGHTING:BACK UP LIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V077000·2022-02-11

    Chrysler Recalls 2017-2018 Pacifica Plug-In Hybrids for Fire Risk

    Chrysler is recalling 2017-2018 Pacifica Plug-In Hybrid vehicles because a fire can occur while parked. Owners should park outside and avoid recharging until repairs are completed.

    Product
    CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V078000·2022-02-11

    Mercedes-Benz Recalls 2021 GLB 250 Vehicles for Front Air Bag Defect

    Mercedes-Benz is recalling 2021 GLB 250 vehicles because an incorrect front driver's air bag module may not restrain occupants or could detach during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·004-2022·2022-02-11

    Great American Cobbler Recalls Chicken Pot Pie for Undeclared Soy Allergen

    Great American Cobbler LLC is recalling Creole Style Chicken Pot Pie products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Great American Cobbler Company LLC — Great American Cobbler Company, LLC, Recalls Creole Style Chicken Pot Pie Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighCPSC·22721·2022-02-10

    2022 Can-Am Outlander ATVs Recalled Due to Speedometer Crash Hazard

    BRP U.S. Inc. is recalling about 1,300 2022 Can-Am Outlander ATVs because the speedometer can display half the vehicle's true speed, creating a crash hazard. Consumers should stop using the vehicles and contact a Can-Am dealer for a free repair.

    Product
    2022 Can-Am Outlander ATVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22722·2022-02-10

    Serta Perfect Sleeper Mattresses Recalled for Fire Hazard

    Serta is recalling about 800 Perfect Sleeper mattresses because they fail to meet federal flammability standards, creating a fire hazard. No injuries have been reported.

    Product
    Serta® Perfect Sleeper® Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V076000·2022-02-10

    2022 Thor Motor Coach Motorhomes Rear Ladder Installation Defect Recall

    Thor Motor Coach is recalling 2022 ACE, Freedom Traveler, Hurricane, and Windsport motorhomes. The rear ladder may have been installed on the wrong side, which could break while in use and cause injury.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH ACE, FREEDOM TRAVELER, HURRICANE, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22078·2022-02-10

    WORX 13 Amp 1900 PSI Electric Pressure Washers Recalled for Hose Separation

    Positec USA is recalling about 17,630 WORX Brand 13 Amp 1900 PSI Electric Pressure Washers because the sprayer hose can separate from the spray wand during use, posing an impact injury hazard. Four minor injuries including cuts and bruises have been reported.

    Product
    WORX® Brand 13 Amp 1900 PSI Electric Pressure Washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22720·2022-02-10

    Ski-Doo 2022 Snowmobiles Recalled Due to Speedometer Crash Hazard

    BRP is recalling approximately 400 Ski-Doo 2022 snowmobiles because the speedometer may display half the vehicle's true speed, creating a crash hazard. Consumers should stop using the recalled snowmobiles and contact a Ski-Doo dealer for free repair.

    Product
    Ski-Doo Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·22723·2022-02-10

    Shop LC Electric Space Heaters Recalled Due to Fire and Burn Hazards

    Shop LC is recalling about 4,500 personal electric space heaters that can overheat, posing fire and burn hazards. Consumers should stop using them immediately and return the product for a refund.

    Product
    Personal Electric Space Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2022·2022-02-09

    Medroxyprogesterone Acetate Injection Recalled for Sterility Assurance

    Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.

    Product
    Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0530-2022·2022-02-09

    Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures

    Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0529-2022·2022-02-09

    Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure

    Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.

    Product
    Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0480-2022·2022-02-09

    COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval

    CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.

    Product
    CovClear COVID-19 Rapid Antigen Test, ATG 900-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0481-2022·2022-02-09

    COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale

    Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.

    Product
    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2022·2022-02-09

    OXY-1 System Console Experiences Power Interruption During Use

    OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.

    Product
    OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0552-2022·2022-02-09

    Premier Rotaclone Medical Device Recalled Due to Improper Storage Conditions

    Medline Industries is recalling 34 units of the Premier Rotaclone (Lot 696004N116) due to improper storage in temperature-controlled settings instead of required refrigeration. This may affect device performance or safety.

    Product
    Premier Rotaclone, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0627-2022·2022-02-09

    Delizza Chocolate Cream Puffs Recalled for Metal Contamination

    Delizza Belgian Mini Chocolate Cream Puffs are recalled due to small metal pieces found in the bakery's palm oil silo that could not be reliably detected by the manufacturer's metal detector system.

    Product
    Delizza BELGIAN MINI CHOCOLATE CREAM PUFFS NET WT. 14.1 oz (400g) 30 CREAM PUFFS PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORATION PARKWAY, BATTLEBORO, NC 27809 UPC 6 76670 00402 2
    Category
    Food
    Distribution
    4 states
  • HighCPSC·22077·2022-02-09

    Home Easy Geek Heat Personal Heaters Recalled for Fire Hazard

    Home Easy is recalling about 3,000 Geek Heat DH-QN06 personal heaters because the toggle power switch can spark and cause a fire. The company has received three reports of fires caused by the switch, though no injuries or property damage have been reported.

    Product
    Personal Electric Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2022·2022-02-09

    DIXI Microdeep Depth Electrode sterile barrier packaging defect

    DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2022·2022-02-09

    Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk

    DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2022·2022-02-09

    Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity

    Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.

    Product
    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V073000·2022-02-09

    Mercedes-Benz Recalls 2021 Sprinter Vans for Incorrect Weight Labeling

    Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because the gross vehicle weight rating may be incorrectly stated on the tire and loading label.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 1500, SPRINTER 3500, SPRINTER 2500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2022·2022-02-09

    DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2022·2022-02-09

    ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results

    Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.

    Product
    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2022·2022-02-09

    Spinal Fusion Implant Insert Recalled for Assembly Defect

    XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.

    Product
    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0555-2022·2022-02-09

    Young Dental Sterilization Indicator Labels May Contain Wrong Type

    YOUNG DH Dry Heat Indicator Labels used in healthcare sterilization may contain TTS Indicator Labels instead. Healthcare providers should verify package contents before use to ensure proper sterilization monitoring.

    Product
    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0623-2022·2022-02-09

    Abby's Bakery frozen bread dough recalled due to glass contamination risk

    Abby's Bakery Homestyle White Bread Dough may contain glass fragments. The affected product (lots 21340-31 to 21340-36) should be discarded.

    Product
    Abbys Bakery Homestyle White Bread Dough. Product number 93596. Keep Frozen. 4-1 lb. loaves. Net Wt. 4 lbs. (1.81kg) UPC 40730-93596. Abby's Bakery, Wadena, MN 56482
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0549-2022·2022-02-09

    Philips eCareManager versions recalled due to unapproved Sentry Score software

    Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.

    Product
    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22073·2022-02-09

    Stack Em' Up Books Recalls Children's Stackable Toys for Excessive Lead Paint

    Stack Em' Up Books is recalling Adam the Apple children's stackable toys because the surface paint contains lead levels that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    Adam the Apple™ Children's Stackable Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2022·2022-02-09

    Pelvic floor repair device may lack required packaging component

    FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.

    Product
    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2022·2022-02-09

    DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V070000·2022-02-09

    2022 BMW X4 and Related Models Transmission Rollaway Risk Recall

    BMW is recalling certain 2022 330i, 530i, X3, and X4 vehicles because the transmission mechatronics unit may not have been properly assembled, potentially causing an internal leak that could lead to vehicle rollaway and crash risk.

    Product
    BMW — BMW X4, X3, 330I, 530I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0629-2022·2022-02-09

    Taste of Inspirations Creme Puffs Recalled Due to Metal Contamination

    Taste of Inspirations Creme Puffs are being recalled due to the potential presence of metal pieces in the product. The contamination was discovered in the bakery palm oil silo used during production.

    Product
    taste of Inspirations CREME PUFFS Whipped Cream Filled Pastry NET WT 13.2 OZ (375g) 30ct UPC: 7 25439 99597 9, DISTRIBUTED BY: DZA BRANDS, LLC SALISBURY, NC 28247
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0628-2022·2022-02-09

    Delizza Belgian Mini Cream Puffs Recalled Due to Metal Contamination

    Poppies International is recalling Delizza Belgian Mini Cream Puffs due to metal fragments found in the palm oil silo. The metal was not consistently detected during production screening.

    Product
    Delizza BELGIAN MINI CREAM PUFFS WHIPPED FILLING MADE WITH FRESH CREAM NET WT 13.2 oz (375g) PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORATION PARKWAY, BATTLEBORO, NC 27809 UPC: 6 76670 00107 6, and NET WT. 3lb 5 oz. (1.5kg) 120ct UPC: 6 76670 00800 6
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0539-2022·2022-02-09

    DIXI Medical Depth Electrodes recalled for potential sterile packaging defect

    DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2022·2022-02-09

    DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0625-2022·2022-02-09

    Walla Walla Cheese Company Cheddar Curds Recalled for Under Pasteurization

    Walla Walla Cheese Company is recalling AJ's Walla Walla Sweet Onion Mustard Cheddar Curds because the cheese was made from under pasteurized milk.

    Product
    Walla Walla Cheese Company AJ s Walla Walla Sweet Onion Mustard Cheddar Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags. Net wt. 10 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0536-2022·2022-02-09

    DIXI Microdeep Depth Electrode packaging deformation poses sterility risk

    DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V074000·2022-02-09

    Maintainer Recalls 2021-2022 Truck-Mounted Cranes Due to Fire Risk

    Maintainer is recalling 2021-2022 truck-mounted cranes because an incorrectly installed guard may damage fuel hoses or cables, increasing fire risk.

    Product
    MAINTAINER — MAINTAINER CRANE W/ SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22072·2022-02-09

    Petzl Scorpio Eashook Lanyards with Carabiners Recalled for Fall Risk

    Petzl is recalling about 230 Scorpio Eashook Lanyards with Carabiners because the carabiner's automatic gate-closing system can malfunction, creating a risk of serious injury or death.

    Product
    Scorpio Eashook Lanyards with Carabiners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2022·2022-02-09

    INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled

    Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.

    Product
    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2022·2022-02-09

    FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22076·2022-02-09

    Escalade Sports Tennis Tables Recalled for Fall and Injury Hazards

    Escalade Sports is recalling about 5,200 tennis tables sold at Target from September to November 2021 because the table can collapse when leaned against, posing a fall hazard. The company has received 78 reports of collapse, including four reports of minor injuries.

    Product
    Escalade Sports Tennis Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0630-2022·2022-02-09

    Wayfare Dairy Free Butter recalled for suspected mold growth

    WayFare Health Foods is recalling Wayfare Dairy Free Butter Salted & Whipped (610 cases) for suspected mold growth. Affected products were distributed to food distributors and consumers online across multiple states.

    Product
    Wayfare Dairy Free Butter Salted & Whipped,
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0547-2022·2022-02-09

    Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia

    Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.

    Product
    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V072000·2022-02-09

    Altec Recalls 2019-2021 Aerial Devices Due to Bolt Failure Risk

    Altec is recalling 2019-2021 ATTXX-M/P/S aerial devices because over-tightened bolts in the rotation bearing may break, risking separation of the pedestal and turntable.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0626-2022·2022-02-09

    Walla Walla Cheese Company Mad Curds Recalled for Underpasteurized Milk

    Walla Walla Cheese Company has recalled Mad Curds produced from underpasteurized milk. The product was distributed in Oregon and Washington.

    Product
    Walla Walla Cheese Company Mad Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags - net wt. 5 lbs. and 10 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0541-2022·2022-02-09

    DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility

    DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its Tyvek bag.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0624-2022·2022-02-09

    Walla Walla Cheese Cheddar Curds recalled due to under-pasteurization

    Walla Walla Cheese Company is recalling Cheddar Curds due to under-pasteurization of the milk used in production, which may not eliminate potentially harmful bacteria.

    Product
    Walla Walla Cheese Company Cheddar Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags. Net wt. 5 lbs.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0557-2022·2022-02-09

    Chameleon PTA Balloon Catheter difficult protector sleeve removal risk

    The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.

    Product
    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2022·2022-02-09

    Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect

    LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.

    Product
    Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
    Category
    Medical Device
    Distribution
    7 states
  • HighCPSC·22075·2022-02-09

    Pittsburgh Automotive Pneumatic Roller Seats Recall Due to Fall Hazard

    Harbor Freight Tools is recalling Pittsburgh Automotive pneumatic roller seats because the connection between the seat and post can break, causing users to fall. The company has received 96 reports of seat welds breaking, including 10 reports of minor injuries.

    Product
    Pittsburgh Automotive Pneumatic Roller Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2022·2022-02-09

    HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage

    HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.

    Product
    HARDY DIAGNOSTICS CatScreen, 25dsk/vial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22071·2022-02-09

    Children's Nightgowns Recalled for Flammability Standards Violation

    AllMeInGeld children's nightgowns fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 3,900 units were sold on Amazon.com from October 2017 through June 2021.

    Product
    Children's Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2022·2022-02-09

    Backache & Muscle Relief Drug Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.

    Product
    Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2022·2022-02-09

    DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.

    Product
    DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2022·2022-02-09

    Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations

    Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.

    Product
    PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2022·2022-02-09

    Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations

    Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.

    Product
    Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2022·2022-02-09

    MidNite Natural Sleep Aid Chewable Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 90,072 bottles distributed across the United States.

    Product
    MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0519-2022·2022-02-09

    Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.

    Product
    Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.

    Product
    PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0472-2022·2022-02-09

    DBI 357 Super Magnum Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling DBI 357 Super Magnum Quick Energy Stimulant caffeine tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall includes 36-count, 100-count, and 500-count bottles, as well as 3-count packets.

    Product
    DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2022·2022-02-09

    Multi Symptom Cold Relief tablets recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) deviations.

    Product
    Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2022·2022-02-09

    Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations

    Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.

    Product
    Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2022·2022-02-09

    Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed

    Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2022·2022-02-09

    SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.

    Product
    SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2022·2022-02-09

    Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.

    Product
    Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2022·2022-02-09

    Cough & Cold Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.

    Product
    CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2022·2022-02-09

    Pain & Sinus Reliever tablets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling 887,000 packets of Pain & Sinus Reliever (acetaminophen/phenylephrine) tablets nationwide due to cGMP manufacturing deviations. The recalled product is identified by Lot #AK9527 with expiration date 03/2022.

    Product
    Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2022·2022-02-09

    Pain Terminator Extra Strength Pain Relief Drug Recall

    Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.

    Product
    PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2022·2022-02-09

    Olympus Spiration Valve System mislabeled with incorrect model number

    Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.

    Product
    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2022·2022-02-09

    Cold Terminator decongestant recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.

    Product
    COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2022·2022-02-09

    Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations

    Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.

    Product
    Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2022·2022-02-09

    Drug Recall: Back Pain-Off Tablets Over cGMP Violations

    Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.

    Product
    Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
    Category
    Drug
    Distribution
    Distributed nationwide

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