The Recall Desk

Archive

February 2024 recalls

677 recalls were announced in February 2024.

What the numbers show

Critical
21
Severe
160
High
457
Moderate
38
Low
1

Of the 677 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

Which agencies issued them

501–600 of 677

  • HighFDA (Food)·F-0797-2024·2024-02-07

    Hot Sauce Recalled for Missing Wheat Allergen Labeling

    Benny T's Vesta Dry Hot Sauce is recalled because its label does not list wheat and other required ingredient common names, posing a risk to consumers with wheat allergies.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE GHOST NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99498 0 (Habanero & Bhut Joloki
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-0869-2024·2024-02-07

    Knee replacement patella component recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.

    Product
    SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V077000·2024-02-07

    2024 Kia Telluride recalled for engine valve spring failure

    Kia is recalling certain 2024 Telluride vehicles because engine valve springs may break while driving. This could cause loss of drive power and increased risk of fire.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0801-2024·2024-02-07

    Benny T's Vesta hot sauce recalled for undeclared wheat allergen

    Benny T's Vesta Dry Hot Sauce is recalled because wheat is not listed on the label, despite being present in the breadcrumbs ingredient. Consumers with wheat allergies should not consume this product.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE VERY HOT NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99499 7 (Habanero & Scotch B
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-0915-2024·2024-02-07

    Knee Replacement Implant Recall Due to Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling LARGE PRIMARY REV.TIB.INSERT-DURACON knee implants manufactured with aged UHMWPE material that may have elevated oxidation levels. Affected patients should consult their healthcare provider.

    Product
    LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2024·2024-02-07

    Knee replacement inserts recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2024·2024-02-07

    Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement

    Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2024·2024-02-07

    MRI Machine Coil Seal Adhesive May Create Sharp Edges

    The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.

    Product
    Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2024·2024-02-07

    Knee replacement implant recalled due to potential material degradation

    Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures

    American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0274-2024·2024-02-07

    Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications

    Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2024·2024-02-07

    Knee replacement tibial insert recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2024·2024-02-07

    Knee replacement implant insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2024·2024-02-07

    Philips Ingenia 3.0T CX MRI: Loose Coil Seal May Cause Sharp Edges

    Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during scanning.

    Product
    Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2024·2024-02-07

    FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

    FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2024·2024-02-07

    Knee Replacement Component Recalled Due to Potential Material Degradation

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2024·2024-02-07

    Philips Azurion X-ray System Software Issue Causes Restart and Imaging Loss

    Philips Azurion interventional x-ray systems may continuously restart due to a software issue, causing loss of imaging functionality and data. If this occurs during a procedure, the procedure may be delayed or aborted.

    Product
    Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2024·2024-02-07

    Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk

    Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02072024-01·2024-02-07

    Frozen Chicken Pilaf Recalled Due to Rock Contamination

    USDA issued a public health alert for frozen Trader Joe's chicken pilaf due to rock contamination. One consumer reported a dental injury.

    Product
    Mama Vicky's Inc. — FSIS Issues Public Health Alert For Frozen Ready-To-Eat Chicken Pilaf Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2024·2024-02-07

    Knee Replacement Insert May Degrade from Oxidized Raw Material

    Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2024·2024-02-07

    EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk

    Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.

    Product
    EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2024·2024-02-07

    Knee Replacement Implant Recalled for Potential Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting performance.

    Product
    SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2024·2024-02-07

    Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure

    American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2024·2024-02-07

    Custom Anesthesia Kits Recalled Over Sterilization Validation Failure

    American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.

    Product
    Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2024·2024-02-07

    Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure

    American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2024·2024-02-07

    Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment

    American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0284-2024·2024-02-07

    Rifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications

    Lupin Pharmaceuticals recalls Rifampin 300mg capsules (lot A200817, exp 1/2024) due to subpotency and failed impurities/degradation specifications. Patients should consult their doctor before stopping medication.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0970-2024·2024-02-07

    Vortex Surgical ACTU8 Forceps Recalled Due to Residue on Forceps Tips

    Vortex Surgical has voluntarily recalled 800 ACTU8 FORCEPS units due to residue identified on forceps tips. The recall affects surgical instruments distributed in the US (OH, WA, MN, MI, IA) and Korea.

    Product
    Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0283-2024·2024-02-07

    Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures

    Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0900-2024·2024-02-07

    Scorpio NRG Tibial Bearing Insert Assembly Recall Due to Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Bearing Insert Assemblies manufactured with raw material over 5 years old, which may develop elevated oxidation affecting implant durability.

    Product
    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Degradation

    Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2024·2024-02-07

    Tank hose assembly recalled for incorrect material and missing perforations

    AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.

    Product
    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2024·2024-02-07

    Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure

    American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2024·2024-02-07

    NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail

    A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.

    Product
    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0936-2024·2024-02-07

    EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

    Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

    Product
    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0276-2024·2024-02-07

    Budesonide Extended-Release Tablets recalled for failed dissolution specifications

    Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.

    Product
    Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0872-2024·2024-02-07

    Knee replacement implant recalled for material oxidation risk

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.

    Product
    SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2024·2024-02-07

    Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures

    American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2024·2024-02-07

    Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates

    Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.

    Product
    MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2024·2024-02-07

    Surgical kits for childbirth recalled for sterilization and functionality risks

    American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2024·2024-02-07

    FX SHOULDER Centered Glenosphere with Screw may contain eccentric component

    FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.

    Product
    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2024·2024-02-07

    IV Phenylephrine Bags Recalled Due to Potential Double-Dose Delivery System Malfunction

    Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.

    Product
    PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2024·2024-02-07

    Rifampin Capsules Recalled Due to Failed Impurity and Degradation Specification

    Amerisource Health Services is recalling Rifampin 150 mg capsules because they failed to meet impurity and degradation specifications. The recall affects 1,568 cartons distributed nationwide.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0812-2024·2024-02-07

    ToYou Snacks Mango Yogurt Bars Recalled for Undeclared Soy Allergen

    Font Group of America Corp. is recalling ToYou Snacks brand Mango Yogurt bars due to undeclared soy allergen. Affected units were distributed in the United States.

    Product
    Mango Yogurt bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0867-2024·2024-02-07

    Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging

    Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.

    Product
    MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0811-2024·2024-02-07

    Mint Dark Chocolate bars recalled for undeclared soy allergen

    Font Group of America is recalling Mint Dark Chocolate bars (ToYou Snacks Brand) due to undeclared soy allergen. Consumers with soy allergies should not consume the product.

    Product
    Mint Dark Chocolate bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0889-2024·2024-02-07

    Total Knee Replacement Component Recalled Due to Oxidation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0816-2024·2024-02-07

    Coconut Mocha snack bars recalled for undeclared soy allergen

    Font Group of America Corp. is recalling ToYou Snacks Brand Coconut Mocha bars (5,670 units) distributed in the United States due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Coconut Mocha, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2024·2024-02-07

    Ophthalmic procedural kits recalled due to inadequate sterilization validation

    American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2024·2024-02-07

    Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement

    TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.

    Product
    Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0796-2024·2024-02-07

    Dried plums recalled due to undeclared sulfites

    Win Luck Trading Inc recalled Tasty Snacks Plum Queen Dried Plums (7 ounce cans, code 12122023) because the product contains undeclared sulfites, a food allergen.

    Product
    Tasty Snacks Plum Queen Dried Plums Net Weight 200G (7OZ) Packaged in cans. 30 cans per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0833-2024·2024-02-07

    Orthopedic surgical kits recalled for unassessed external component sterilization

    American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.

    Product
    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2024·2024-02-07

    Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

    American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2024·2024-02-07

    Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures

    Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.

    Product
    EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2024·2024-02-07

    Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation

    Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.

    Product
    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0798-2024·2024-02-07

    Benny T's hot sauce recalled for undisclosed wheat allergen

    Benny T's Vesta Dry Hot Sauce is recalled because the label does not disclose wheat, a major allergen present in the breadcrumb ingredient. People with wheat allergies or celiac disease should not consume this product.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE HOT NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99497 3 (Jalapeno & Habanero)
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0806-2024·2024-02-07

    Aldi Choceur Burnt Caramel Chocolate Bars Recalled for Undeclared Coconut

    Astor Chocolate Corp. has recalled Aldi Choceur Burnt Caramel Chocolate Bars due to undeclared coconut, a common allergen. The voluntary recall involves 1,092 units distributed to a distribution center in Florida.

    Product
    Aldi Choceur Burnt Caramel Chocolate Bars, Net Wt. 1.75oz. UPC 4099100202809
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0815-2024·2024-02-07

    ToYou Snacks Banana Foster Bars Recalled for Undeclared Soy Allergen

    Font Group of America Corp. is recalling ToYou Snacks Banana Foster bars due to undeclared soy allergen. Approximately 5,670 units were distributed in the United States.

    Product
    Banana Foster bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0800-2024·2024-02-07

    Hot Sauce Recalled for Missing Wheat Allergen Labeling

    Benny T's Vesta Dry Hot Sauce is recalled for labeling that fails to disclose wheat and other ingredient common names. The missing allergen information poses a risk to consumers with wheat allergies.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE SCORPION NWT WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99491 1 (Trinidad Moruga Sc
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0814-2024·2024-02-07

    Chocolate Mango Snack Bars Recalled for Undeclared Soy Allergen

    Font Group of America Corp. is recalling Chocolate Mango bars due to undeclared soy allergen. The recall affects approximately 5,670 units distributed in the United States.

    Product
    Chocolate Mango bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0799-2024·2024-02-07

    Benny T's Vesta Hot Sauce Recalled for Undeclared Wheat Allergen

    Benny T's Vesta Dry Hot Sauce is recalled because wheat is not declared in the ingredient statement. The missing wheat label poses a risk to consumers with wheat allergies.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE REAPER NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99490 4 (Carolina Reaper)
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0810-2024·2024-02-07

    Notoginseng Gout Granule Recalled for Undeclared Diclofenac and Dexamethasone

    8th Ave Pharmacy recalls Notoginseng Formula Special Gout Granule because the product contains undeclared pharmaceutical ingredients: Diclofenac and Dexamethasone Acetate. Consumers should not use this product.

    Product
    Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON BAY, KOWLOON; "Nourish and helps the kidney with detoxification. Effectively dissolves uric acid crystals in joints. Has a
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-0813-2024·2024-02-07

    Salted Caramel Dark Chocolate Bars Recalled for Undeclared Soy Allergen

    Font Group of America Corp. is recalling Salted Caramel Dark Chocolate bars due to undeclared soy allergen. The product may pose a risk to consumers with soy allergies.

    Product
    Salted Caramel Dark Chocolate bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0888-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Material Oxidation Risk

    Howmedica Osteonics recalled Scorpio Total Knee prosthetics with UHMWPE components produced from raw material over 5 years old, which may develop elevated oxidation and affect implant properties.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2024·2024-02-07

    Knee replacement devices recalled due to potential material degradation

    Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2024·2024-02-07

    SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk

    Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2024·2024-02-07

    Surgical Procedure Kits Recalled Due to Improper Sterilization

    American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2024·2024-02-07

    PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk

    Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2024·2024-02-07

    Tibial Knee Replacement Implants Recalled Due to Material Oxidation

    Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

    Product
    TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2024·2024-02-07

    Knee replacement poly insert recalled due to material oxidation risk

    Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation risk

    Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2024·2024-02-07

    Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

    Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

    Product
    Achieva XR. Model (REF) Numbers 781153, 781253.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2024·2024-02-07

    Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line

    An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.

    Product
    ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.

    Product
    P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2024·2024-02-07

    SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk

    Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2024·2024-02-07

    Knee Replacement Device Recalled Due to Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2024·2024-02-07

    Knee replacement tibial insert recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2024·2024-02-07

    Knee replacement implant insert recalled due to material oxidation risk

    Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2024·2024-02-07

    Knee replacement inserts recalled due to material oxidation risk

    P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.

    Product
    P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2024·2024-02-07

    Knee replacement implant recall due to material oxidation risk

    Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.

    Product
    LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2024·2024-02-07

    Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure

    Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.

    Product
    EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2024·2024-02-07

    Philips Achieva 1.5T MRI system recalled for defective coil seal

    Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade patients during scanning.

    Product
    Achieva 1.5T Initial system. Model (REF) Numbers 781178.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2024·2024-02-07

    Knee replacement implants recalled for potential material degradation

    Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.

    Product
    DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2024·2024-02-07

    SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0877-2024·2024-02-07

    Knee Replacement Implant Insert Recalled Due to Material Degradation Risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.

    Product
    SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2024·2024-02-07

    Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

    The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.

    Product
    Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2024·2024-02-07

    Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail

    Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.

    Product
    Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2024·2024-02-07

    Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss

    American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2024·2024-02-07

    SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk

    Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2024.