The Recall Desk

Archive

July 2023 recalls

787 recalls were announced in July 2023.

What the numbers show

Critical
65
Severe
365
High
307
Moderate
50

Of the 787 recalls this month scored against our rubric, 8% are Critical, 46% are Severe.

701–787 of 787

  • SevereNHTSA·23E050000·2023-07-05

    Lippert Recalls Curt Axles Due to Improperly Tightened U-Bolts

    Lippert is recalling certain Curt 7000 and 8000 lb axles because improperly tightened U-bolts may allow the axle to move out of position, increasing crash risk.

    Product
    SUSPENSION:REAR:SPRINGS:LEAF SPRING ASSEMBLY:U-BOLT, LEAF SPRING TO AXLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1840-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Hazard in Teleflex Slick Set

    Teleflex is recalling Slick Set Uncuffed Endotracheal Tube kits due to reports of 15mm connector disconnection. 20,662 units have been distributed nationwide, including Puerto Rico.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1951-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recalled by Teleflex

    Teleflex recalls 76,060 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. A disconnected connector could compromise ventilation in critical care settings.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1881-2023·2023-07-05

    Endotracheal Tubes Recalled for 15mm Connector Disconnection

    TELEFLEX LLC recalls 2,520 endotracheal tubes (model REF 112080055) due to reports of 15mm connector disconnection. The disconnection could compromise airway function during critical care use.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1833-2023·2023-07-05

    Teleflex Slick Set Endotracheal Tube Connector Disconnection Recall

    Teleflex is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports of disconnection of the 15mm connector from the endotracheal tube. The affected units were distributed nationwide.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1924-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

    Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. Approximately 2,980 units were distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2023·2023-07-05

    Teleflex Slick Set Endotracheal Tube Connector May Disconnect

    Teleflex recalled 720 units of its Slick Set Cuffed Endotracheal Tube and Stylet Set due to reports of connector disconnection. The recall affects units distributed nationwide including Puerto Rico.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1995-2023·2023-07-05

    MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Patient Burn Hazard

    Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.

    Product
    MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2023·2023-07-05

    Flexi-Set Endotracheal Tubes Recalled for 15mm Connector Disconnection

    Teleflex is recalling 17,551 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide after reports of the 15mm connector disconnecting from the tube.

    Product
    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recalls 14,480 Units

    Teleflex is recalling 14,480 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube during use.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2023·2023-07-05

    Endotracheal Tube and Stylet Set Connector May Disconnect During Use

    TELEFLEX is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1875-2023·2023-07-05

    Endotracheal Tubes Recalled for 15mm Connector Disconnection

    TELEFLEX is recalling approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2023·2023-07-05

    Flexi-Set Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of the 15mm connector disconnecting from the tube, posing a serious risk in critical care settings.

    Product
    Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1929-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Risk - Teleflex Magill Recall

    TELEFLEX LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was distributed nationwide.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2023·2023-07-05

    Slick Set Uncuffed Endotracheal Tubes recalled for connector disconnection risk

    Teleflex is recalling Slick Set Uncuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube. This disconnection could result in loss of airway during patient care.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1940-2023·2023-07-05

    Endotracheal Tube 15mm Connector Disconnection Recall

    Teleflex is recalling endotracheal tubes after reports that the 15mm connector may disconnect from the tube. The recall affects 36,135 units distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2023·2023-07-05

    Preformed AGT Oral Endotracheal Tubes Recalled for Connector Disconnection

    TELEFLEX is recalling approximately 8,620 Preformed AGT Oral Endotracheal Tubes distributed nationwide due to reports of disconnection of the 15mm connector from the tube.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2023·2023-07-05

    Slick Set Endotracheal Tubes Recalled for Connector Disconnection

    Teleflex is recalling 870 units of Slick Set Uncuffed Endotracheal Tubes nationwide due to reports of disconnection of the 15mm connector from the tube.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2023·2023-07-05

    Oral Endotracheal Tubes Recalled for 15mm Connector Disconnection Risk

    Teleflex LLC is recalling 19,842 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. Affected devices were distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1941-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall Due to Device Malfunction

    Teleflex is recalling 20,042 endotracheal tubes due to reports of 15mm connector disconnection that could compromise airway management. The FDA classified this as a Class I recall.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1998-2023·2023-07-05

    Patient Return Electrode Recalled Due to Burn Reports During Surgery

    Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.

    Product
    MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2023·2023-07-05

    Teleflex Endotracheal Tubes: FDA Recalls 1110 Units for Connector Disconnection

    Teleflex is recalling 1,110 endotracheal tubes due to reports of 15mm connector disconnection. The affected units are distributed nationwide in the US and Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1853-2023·2023-07-05

    Flexi-Set Cuffed Endotracheal Tube and Stylet Connector Disconnection Recall

    TELEFLEX LLC is recalling 13,710 units of Flexi-Set Cuffed Endotracheal Tubes due to reports of connector disconnection. The 15mm connector may separate from the tube during use.

    Product
    Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1936-2023·2023-07-05

    Endotracheal Tubes Recalled for Connector Disconnection Risk

    Teleflex LLC is recalling 11,188 endotracheal tubes due to reports of 15mm connector disconnection. The defect affects this critical airway management device nationwide.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1884-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection

    Teleflex is recalling 47,520 endotracheal tubes due to reported 15mm connector disconnection. The FDA classified this as a Class I recall; disconnected tubes could compromise airway management.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1933-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

    Teleflex is recalling 190 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. This disconnection could compromise airway management and ventilation.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2023·2023-07-05

    Knee prosthesis femoral segment recalled for specification non-compliance

    Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2010-2023·2023-07-05

    Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect

    Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.

    Product
    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2023·2023-07-05

    PushTracker E2 watch app may crash, disabling wheelchair motor controls

    Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.

    Product
    PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2002-2023·2023-07-05

    Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw

    B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.

    Product
    Perifix¿ / Epidural anesthesia kit (10 count carton)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2023·2023-07-05

    Vanta Implantable Neurostimulator May Become Unresponsive During Cardioversion

    Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.

    Product
    Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1016-2023·2023-07-05

    Mott's Applesauce Recalled for Elevated Patulin Levels

    MOTTS LLP is recalling Mott's No Sugar Added Applesauce due to elevated patulin levels. The affected products have Best By dates of August 13-14, 2024, and were distributed across the U.S., Bermuda, and the Dominican Republic.

    Product
    Mott s no sugar added applesauce 6 pack 3.9 oz (111g) Containers 23.4 oz (666g). Individual units are packaged in plastic cups and placed in a cardboard sleeve of 6 sups with 12 sleeves to a case. Retail unit UPC is 14800000078 . Case label UPC is 10014800000075
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2043-2023·2023-07-05

    Access Hybritech p2PSA Reagent Recalled for Insufficient Blocking Reagent

    Beckman Coulter is recalling Access Hybritech p2PSA diagnostic reagent kits with insufficient blocking reagent concentration. Three lot numbers affecting 987 kits were distributed in the US and internationally.

    Product
    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2006-2023·2023-07-05

    Voalte Patient Safety software may fail to alert caregivers of safety changes

    Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.

    Product
    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2023·2023-07-05

    ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components

    A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.

    Product
    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2024-2023·2023-07-05

    VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results

    Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.

    Product
    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2023·2023-07-05

    LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects

    The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2050-2023·2023-07-05

    Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect

    Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.

    Product
    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2037-2023·2023-07-05

    Dental Implant Abutments Recalled Due to Lack of FDA Clearance

    Implant Direct Sybron is recalling LEGACY SMARTBASE dental abutments distributed without FDA clearance. Performance characteristics have not been adequately established.

    Product
    LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2023·2023-07-05

    Verigene nucleic acid test kits recalled for rare false-negative results

    Luminex Corporation recalls Verigene nucleic acid test kits that may rarely produce false-negative results due to hydrophobic properties in certain FLOQSwab lots. False-negative results could fail to detect enteric pathogens in patient samples.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1012-2023·2023-07-05

    Rudolphs OnYums Onion Snack Rings recalled for undeclared wheat and artificial colors

    Rudolphs OnYums Onion Snack Rings are recalled for undeclared wheat and artificial colors. Consumers with wheat allergies should not consume this product.

    Product
    Rudolphs OnYums Onion Flavored Snack Rings 3 oz. UPC 0-24622-57106-9 packaged in metallized film bags, 15 bags per case
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-0888-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations

    The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.

    Product
    StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2023·2023-07-05

    Integre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission

    Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.

    Product
    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1301-2023·2023-07-05

    Sun Wave Brand Jelly Cups Recalled Due to Potential Choking Hazard

    Richin Trading Inc is recalling Sun Wave Brand Jelly Cups (Lychee Flavor) with multiple lot numbers due to a potential choking hazard. The recall affects 141,192 units distributed across 17 U.S. states.

    Product
    Sun Wave Brand Jelly Cup (Lychee Flavor); Made in Taiwan; Item Number 12152; UPC 715685121529; Net Weight 35.27 oz. (1000 g) Sun Wave Brand Jelly Cup (Lychee Flavor); Made in Taiwan; Item Number 12145; UPC 715685121451; Net Weight 52.91 oz. (1500 g)
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2039-2023·2023-07-05

    RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

    RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

    Product
    Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2051-2023·2023-07-05

    Exactech Ergo Impactor Handle Recalled for Component Dislodgement

    Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.

    Product
    Exactech Ergo Impactor Handle, Catalog #321-09-05.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2009-2023·2023-07-05

    Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes

    Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.

    Product
    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2023·2023-07-05

    Sertera 14 Gauge Biopsy Device: Needle Detachment Risk

    Hologic's Sertera 14 Gauge Biopsy Device may experience inner needle detachment or discharge during use, which could delay breast biopsy surgery. The company is recalling 756 units nationwide.

    Product
    Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1011-2023·2023-07-05

    Cinnamon sticky buns recalled due to undeclared walnuts

    Honest Baking is recalling Cinnamon Sticky Buns With Nuts because they contain undeclared walnuts. The product was distributed to one retailer in New Jersey.

    Product
    Cinnamon Sticky Buns With Nuts 6 Count Net WT 2 LB 1 OZ (935g). Packaged as a singe pack or 6 pack. Packaged in a plastic container.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2020-2023·2023-07-05

    Orthopedic assembly screws with incorrect model number labeling and markings

    AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0879-2023·2023-07-05

    Endometrin Vaginal Inserts Recalled Due to Potential Microbial Contamination

    Ferring Pharmaceuticals is recalling certain lots of Endometrin (progesterone) Vaginal Inserts due to potential microbial contamination resulting from manufacturing deviations.

    Product
    Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2023·2023-07-05

    PushTracker E3 software failure may prevent stopping SmartDrive motor

    A software defect in the PushTracker E3 watch can cause the SmartDrive motor to run uncontrollably, and users may not be able to stop the device using tap controls. Approximately 6,196 units worldwide are affected.

    Product
    PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0891-2023·2023-07-05

    Amphotericin B Liposome Injection Recalled for Subpotency Nationwide

    Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.

    Product
    Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1010-2023·2023-07-05

    Compass USA recalls Fresh To You Chicken Filet Sandwich due to uncooked chicken

    Compass USA is recalling Fresh To You Chicken Filet Sandwich because the chicken was not cooked. Consumers who purchased this product should not consume it.

    Product
    Fresh To You Chicken Filet Sandwich. MGF0635. Net Wt. 8oz. Perishable - Keep Refrigerated. Manufactured By MG Foods, Oak Creek, WI 53154
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2007-2023·2023-07-05

    NaviCare Patient Safety software versions recalled for alert suppression defect

    Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.

    Product
    NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2023·2023-07-05

    Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue

    Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2025-2023·2023-07-05

    Philips Respironics V60 Ventilator recalled for potential gas pathway contamination

    DRE Medical Group recalled 22 Philips Respironics V60 ventilators due to potential contamination in the gas pathway of retrofitted units. These devices may pose a serious health risk to patients.

    Product
    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2038-2023·2023-07-05

    Remel Haemophilus Test Medium Agar Packages Recalled for Performance Failure

    Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.

    Product
    Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2023·2023-07-05

    Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error

    Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2023·2023-07-05

    Knee Prosthesis System Components Recalled for Specification Non-Compliance

    Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2003-2023·2023-07-05

    Design Options Epidural Anesthesia Kit Recalled for Incorrect Filter Straw

    B. Braun Medical is recalling Design Options Epidural Anesthesia Kits because certain units were assembled with an incorrect filter straw. The recall affects approximately 3,560 kits distributed nationwide.

    Product
    Design Options¿ / Epidural anesthesia kit (10 count carton)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0882-2023·2023-07-05

    Homeopathic drug Bebelyn Colic Drops recalled for manufacturing deviations

    Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.

    Product
    Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2041-2023·2023-07-05

    Phadia 2500EE diagnostic instrument recalled for measurement inaccuracy

    Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.

    Product
    Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0887-2023·2023-07-05

    OTC Oral Care Rinse Recalled for Manufacturing Process Deviations

    StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.

    Product
    STELLALIFE VEGA ORAL CARE COCONUT — STELLALIFE VEGA ORAL CARE COCONUT (RISNE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2023·2023-07-05

    Philips DigitalDiagnost C90 X-Ray Systems Software Login Issue

    Philips is recalling DigitalDiagnost C90 diagnostic imaging systems due to a software login issue that may prevent users from logging in to the device. The recall affects 58 units distributed across the U.S. and internationally.

    Product
    DigitalDiagnost C90, Model No. 712034 and 712035
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2021-2023·2023-07-05

    FDA Recalls Immunoassay Quality Control Material for Out-of-Range Values

    Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.

    Product
    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0886-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Rinse for Manufacturing Deviations

    The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.

    Product
    STELLALIFE VEGA ORAL CARE RINSE — STELLALIFE VEGA ORAL CARE RINSE (RINSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2023·2023-07-05

    Drug: Arnica 7 Cream Recalled for Manufacturing Standards Deviations

    Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.

    Product
    Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1009-2023·2023-07-05

    Fanta Orange 12-Pack Mislabeled as Zero Sugar Contains Full Sugar

    Great Lakes Coca-Cola Distribution LLC is recalling Fanta Orange 12-pack cases distributed in California because packages labeled zero sugar actually contain full sugar. Consumers relying on accurate labeling for dietary reasons should not consume affected products.

    Product
    Fanta Orange 12pk (12, 12 oz. cans) Wrap UPC 0 4900003073 0
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0884-2023·2023-07-05

    Drug earache drops recalled due to manufacturing practice deviations

    DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.

    Product
    DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2023·2023-07-05

    Immunoassay Quality Control Material Recalled for Out-of-Range Values

    Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.

    Product
    Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2045-2023·2023-07-05

    Mobile Digital X-Ray System Recall: Software Login Issue Affects Units

    SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.

    Product
    wDR 2.2 Mobile Digital Diagnostic X-Ray System
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2040-2023·2023-07-05

    Diagnostic Test Well Shows Inconsistent Results on Phadia 2500EE

    The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.

    Product
    EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1005-2023·2023-07-05

    Food supplement recalled for elevated lead levels in two products

    Anatox Inc is recalling VIT-RA-TOX Calphonite #38 and Sonne's Calphonite #2 due to elevated lead levels. A total of 6,777 bottles distributed across 27 states are affected.

    Product
    1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an amber glass bottle; 2. Sonne's Calphonite #2, 15 Fl. oz. (444 ml) in an amber glass bottle
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0885-2023·2023-07-05

    Drug Recall: SnoreStop Naso Spray Bulk for cGMP Manufacturing Deviations

    Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.

    Product
    SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2023·2023-07-05

    Homeopathic diarrhea remedy recalled due to manufacturing control deviations

    Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.

    Product
    Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2023·2023-07-05

    Oral care gel recalled nationwide for manufacturing quality deviations

    StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.

    Product
    StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2023·2023-07-05

    Virtual reality therapy device software malfunction prevents treatment progression

    RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.

    Product
    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1006-2023·2023-07-05

    Supplement Recalled Due to Elevated Lead Levels in Multiple States

    Anatox Inc has recalled Sonne's Detoxificant #7 due to elevated lead levels. The voluntary recall affects approximately 2,870 bottles distributed in multiple states.

    Product
    Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber glass bottle.
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0878-2023·2023-07-05

    Tramadol Hydrochloride Tablets Recalled Due to Inadequate Blister Packaging Seal

    The Harvard Drug Group recalls Tramadol Hydrochloride Tablets 50 mg nationwide due to inadequately sealed blister packaging. Affected lot M04343 (expiration 04/2024) may have compromised product integrity.

    Product
    Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2023·2023-07-05

    Drug recall: Kanjo homeopathic pain relief cream with arnica due to manufacturing deviations

    Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.

    Product
    Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0890-2023·2023-07-05

    Drug Oral Care Spray Recalled for Manufacturing Practice Deviations

    StellaLife VEGA Oral Care Spray is being recalled for manufacturing deviations. The product was distributed nationwide; consumers should discontinue use of affected lots.

    Product
    STELLALIFE VEGA ORAL CARE — STELLALIFE VEGA ORAL CARE (SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V465000·2023-07-03

    Mack LR Garbage Trucks Recalled for Windshield Wiper Defect

    Mack is recalling 2023-2024 LR garbage trucks because loose wiper arm nuts may cause wipers to fail, reducing visibility and increasing crash risk.

    Product
    MACK — MACK LR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V466000·2023-07-03

    Polaris Slingshot Rearview Camera May Freeze, Affecting Visibility

    Polaris is recalling certain Slingshot models because the rearview camera image may freeze or display a blank screen after shifting into reverse. This defect reduces rear visibility and increases the risk of a crash.

    Product
    POLARIS — POLARIS SLINGSHOT S, SLINGSHOT R, SLINGSHOT S TECH, SLINGSHOT SL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·029-2023·2023-07-01

    Brookside Beef Wieners Recalled for Undeclared Milk Allergen and Misbranding

    Perdue Premium Meat Company is recalling Brookside beef wieners due to misbranding and an undeclared milk allergen. No illnesses have been reported.

    Product
    Perdue Premium Meat Company, Inc. — Perdue Premium Meat Company, Inc., DBA Alexander & Hornung Recalls Brookside Brand Fully Cooked Beef Wiener Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states

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