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

301–400 of 677

  • HighFDA (Devices)·Z-1032-2024·2024-02-14

    BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2024·2024-02-14

    BD BBL Ertapenem Susceptibility Test Discs Recalled for Accuracy Failures

    BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0849-2024·2024-02-14

    Fresh mozzarella cheese recalled for improper temperature storage

    Greco Sidari fresh mozzarella cheese sold in Ohio, New York, and Pennsylvania was not held at appropriate temperatures, which could affect spoilage and potentially support pathogen growth. Consumers should discard affected products or return them to the retailer.

    Product
    GRANDE .33OZ FRESH CILIEGINE MOZZ 1/3# SUPC/ITEM # 19134P
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1036-2024·2024-02-14

    BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2024·2024-02-14

    Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results

    Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.

    Product
    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2024·2024-02-14

    BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.

    Product
    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0848-2024·2024-02-14

    Fresh mozzarella cheese recalled due to improper temperature storage

    Greco Sidari is recalling GRANDE fresh bocconcini mozzarella because the product was not held at appropriate temperatures during storage. The temperature failure could allow spoilage and pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 1/3# SUPC/ITEM # 19132P
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0826-2024·2024-02-14

    Bellissimo Mascarpone cheese recalled due to improper temperature storage

    Greco Sidari is recalling Bellissimo Mascarpone (1375 cases) distributed to OH, NY, and PA due to improper temperature storage that could allow spoilage and pathogenic growth.

    Product
    BELLISSIMO MASCARPONE SUPC/ITEM # 18270
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0840-2024·2024-02-14

    Goat Cheese Recalled Due to Improper Temperature Storage Conditions

    Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.

    Product
    NORPACO SWEETIE PEPPER GOAT CHEESE 1/5# SUPC/ITEM # 169956
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0825-2024·2024-02-14

    Resers Red Skin Potato Salad Recall Due to Improper Temperature Storage

    Greco Sidari is recalling Resers Red Skin Potato Salad because it was stored at improper temperatures that could allow pathogen growth. The product was distributed in Ohio, New York, and Pennsylvania.

    Product
    RESERS RED SKIN POTATO SALAD 2/8# SUPC/ITEM # 9139
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2024·2024-02-14

    FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results

    BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2024·2024-02-14

    Mastro Capocollo Cured Meat Recalled for Improper Storage Temperature

    Mastro Capocollo cured meat was not held at proper temperatures, potentially allowing pathogen growth. The recall affects 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0829-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Due to Temperature Control Issues

    Greco Sidari is recalling fresh bocconcini mozzarella cheese distributed across three states because it was not held at appropriate temperatures. Improper storage could lead to spoilage and potentially support pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 2/3# SUPC/ITEM # 19132
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1022-2024·2024-02-14

    BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2024·2024-02-14

    BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2024·2024-02-14

    Locatelli Cheese Product Recalled for Improper Temperature Storage

    Locatelli Crema Di Locatelli cheese was recalled because it was not held at appropriate temperatures. Improper holding temperatures could affect food safety by supporting spoilage and pathogen growth.

    Product
    LOCATELLI CREMA DI LOCATELLI 4/1.1# SUPC/ITEM # 8926
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1020-2024·2024-02-14

    Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures

    BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.

    Product
    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0836-2024·2024-02-14

    Galbani Domestic Mascarpone Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1375 cases of Galbani Domestic Mascarpone due to improper storage temperature. The product was not held at appropriate temperatures, which could allow spoilage and support pathogen growth. Affected products were distributed in OH, NY, and PA between November 26, 2023, and January 5, 2024.

    Product
    GALBANI DOMESTIC MASCARPONE 4/5# SUPC/ITEM # 19640
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0828-2024·2024-02-14

    Saputo Stella Cheese Recalled for Improper Temperature Storage

    Saputo Stella cheese distributed in OH, NY, and PA from November 26, 2023 through January 5, 2024 has been recalled due to improper temperature storage. The temperature failure could lead to spoilage and pathogenic growth.

    Product
    SAPUTO STELLA ASGO HLF MLD 11LB SUPC/ITEM # 19009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1007-2024·2024-02-14

    Globus Medical Cannula May Not Be Properly Sterilized

    Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.

    Product
    ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0850-2024·2024-02-14

    Ricotta cheese recalled due to improper temperature storage

    Sopra Ricotta Amalfi manufactured by Greco Sidari is recalled because the product was not held at appropriate temperatures. Improper storage could allow spoilage and pathogen growth.

    Product
    SOPRA RICOTTA AMALFI 1/5# SUPC/ITEM # 193650P
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0831-2024·2024-02-14

    Burrata Cheese Recalled Due to Improper Temperature Storage

    Greco Sidari is recalling Grande Burrata cheese due to improper temperature storage that could support pathogen growth. The affected products were distributed across Ohio, New York, and Pennsylvania.

    Product
    GRANDE BURRATA GRANDE 4/1# SUPC/ITEM # 19137
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1029-2024·2024-02-14

    BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures

    BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.

    Product
    BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2024·2024-02-14

    BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures

    BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0834-2024·2024-02-14

    Ricotta cheese recalled due to improper temperature storage

    GRANDE SOPRAFFINA ricotta cheese was not held at appropriate temperatures, potentially supporting pathogen growth. Affected lots distributed to OH, NY, and PA from November 26, 2023 to January 5, 2024.

    Product
    GRANDE SOPRAFFINA RICOTTA 1/30# SUPC/ITEM # 19536
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0830-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Over Temperature Storage Risk

    Greco Sidari recalled fresh ciliegine mozzarella sold in Ohio, New York, and Pennsylvania due to improper temperature storage that could allow spoilage and potential pathogen growth.

    Product
    GRANDE .33OZ FRESH CILIEGINE MOZZ 2/3# SUPC/ITEM # 19134
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0818-2024·2024-02-14

    Reser's Mashed Red Skin Potatoes recalled due to improper temperature storage

    Reser's Mashed Red Skin Potatoes were not held at appropriate temperatures during distribution in Ohio, New York, and Pennsylvania between November 2023 and January 2024. Improper temperature storage could support pathogen growth and spoilage.

    Product
    RESER'S POTATOE POTATOES MASHED RED SKN 4/5# SUPC/ITEM # 3264
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0860-2024·2024-02-14

    Wegmans Chocolate Croissants Recalled for Undeclared Soy Lecithin

    Wegmans has recalled chocolate croissants containing undeclared soy lecithin due to allergen risk. The recall affects 10,338 units distributed across nine states.

    Product
    5 oz 2pk Chocolate Croissant, bakery box with clear top (UPC 7789050655) and Chocolate Croissant 2 oz, bakery box with clear top (UPC 7789048398)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0988-2024·2024-02-14

    Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk

    The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.

    Product
    Flow-i C30 Anesthesia System, model 6677300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2024·2024-02-14

    BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures

    BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.

    Product
    BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0854-2024·2024-02-14

    Seasoned mushroom product recalled due to improper processing procedures

    Ito-Shoten Seasoned Mushroom is recalled due to lack of filed thermal processing procedures. The product was distributed to CA, NJ, IL, TX, and HI.

    Product
    Ito-Shoten Seasoned Mushroom 200g/7.06 oz. Product of Japan Distributed by Mitsuwa Corporation Torrance, CA 90501
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0979-2024·2024-02-14

    Barco MDSC-8527 NXF Medical Display decoder functionality blocked

    Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.

    Product
    Barco MDSC-8527 NXF, Part Number K9352421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2024·2024-02-14

    Flow-i C20 Anesthesia System cybersecurity vulnerability could enable remote attacks

    The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.

    Product
    Flow-i C20 Anesthesia System, model 6677200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2024·2024-02-14

    Amneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity

    Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0288-2024·2024-02-14

    Omeza Lidocaine Lavage pain relief oil recalled for manufacturing practice violations

    OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.

    Product
    Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2024·2024-02-14

    BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy

    BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2024·2024-02-14

    Flow-i C40 Anesthesia System Recalled for Cybersecurity Vulnerability

    Getinge's Flow-i C40 Anesthesia System (model 6677400) contains a potential cybersecurity vulnerability allowing remote login attacks that could result in denial of service, system tampering, or remote code execution.

    Product
    Flow-i C40 Anesthesia System, model 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2024·2024-02-14

    Brasseler dental burs recalled due to defective latching mechanism

    Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.

    Product
    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2024·2024-02-14

    Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure

    Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0862-2024·2024-02-14

    Wegmans Petite Pastry Tray recalled for undeclared soy lecithin

    Wegmans is recalling 24ct Petite Pastry Tray croissants due to undeclared soy lecithin. The affected products were distributed across nine states from New York to North Carolina.

    Product
    24ct Petite Pastry Tray, plastic tray with white base and clear lid (not a scale label) (UPC: UPC 7789034215)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0843-2024·2024-02-14

    Imported Sharp Provolone Cheese Recalled for Temperature Control Failure

    Greco Sidari is recalling Auricchio imported sharp provolone cheese that was not held at appropriate temperatures, which could promote pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania from November 2023 through January 2024.

    Product
    AURICCHIO IMP SHARP PROV CHEESE 1/17# SUPC/ITEM # 197110
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0838-2024·2024-02-14

    Bel Gioioso Asiago Cheese Recalled for Temperature Storage Failure

    Bel Gioioso Pepato Asiago cheese was not held at appropriate temperature, which could support pathogen growth. Affected products were distributed in Ohio, New York, and Pennsylvania from November 26, 2023 to January 5, 2024.

    Product
    BEL GIOIOSO PEPATO ASIAGO CON PEPPERCORN 10-8OZ SUPC/ITEM # 53478
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0820-2024·2024-02-14

    Gorgonzola Cheese Product Recalled for Improper Temperature Storage

    Greco Sidari recalled Norpaco Gorgonzola Stuff Olive cheese cases distributed in Ohio, New York, and Pennsylvania due to improper temperature storage. The temperature failure could have allowed spoilage and potential pathogen growth.

    Product
    Norpaco GORGONZOLA STUFF OLIVE 1/7.5# SUPC/ITEM # 4481
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0864-2024·2024-02-14

    Wegmans Chocolate and Almond Ready-to-Bake Croissants Recalled for Undeclared Soy

    Wegmans Food Markets is recalling its Ready To Bake Chocolate and Almond Variety Pk croissants due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.

    Product
    Ready To Bake Chocolate and Almond Variety Pk (UPC 87-85300-05013-0)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0861-2024·2024-02-14

    Wegmans Mini Danish Recalled for Undeclared Soy Lecithin

    Wegmans Food Markets recalls 9 oz 10-pack Assorted Mini Danish pastries (UPC 7789050815) because the product contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    9 oz 10pk Assorted Mini Danish, bakery box with clear top (UPC 7789050815)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0851-2024·2024-02-14

    Roast Beef Recalled for Improper Temperature Storage and Pathogen Risk

    Greco Sidari is recalling Joey's Roast Beef Sliced Premium because it was not held at appropriate temperatures, potentially allowing pathogenic growth. The product was distributed in Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    JOEY'S ROAST BEEF SLCD PREMIUM 2/5# SUPC/ITEM # 201172F
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0842-2024·2024-02-14

    Ricotta Cheese Recalled Due to Improper Temperature Storage

    Grande Ricotta Sopraffina (1375 cases) distributed across Ohio, New York, and Pennsylvania from November 2023 to January 2024 is recalled because it was not held at appropriate temperatures, which could support pathogen growth.

    Product
    GRANDE RICOTTA SOPRAFFINA GRANDE 1/3# SUPC/ITEM # 195351
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0827-2024·2024-02-14

    Bel Gioioso Cheese Recalled for Improper Storage Temperature

    Bel Gioioso cheese was not held at appropriate temperatures during distribution, potentially allowing spoilage and pathogen growth. Consumers should not consume affected product.

    Product
    BEL GIOIOSO 12/1# EXACT COMBO SUPC/ITEM # 18304
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0819-2024·2024-02-14

    Garlic-Stuffed Olive Product Recalled Due to Temperature Control Failure

    Greco Sidari is recalling Norpaco garlic-stuffed olives because they were not held at proper temperatures, which could allow spoilage and pathogenic growth. The recall covers 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    Norpaco GARLIC STUFF OLIVE 1/7.5# SUPC/ITEM # 3461
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0839-2024·2024-02-14

    Bel Gioioso Provolone Cheese Recalled Due to Improper Storage Temperature

    Greco Sidari is recalling 1,375 cases of Bel Gioioso Provolone Sharp cheese distributed in Ohio, New York, and Pennsylvania. The recall is due to improper storage temperature that could support pathogen growth.

    Product
    BEL GIOIOSO PROVO SHARP 1/25# SUPC/ITEM # 96317
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0853-2024·2024-02-14

    Conway Caesar Empire Dressing Recalled for Improper Temperature Storage

    Greco Sidari recalled 1,375 cases of Conway Caesar Empire Dressing due to improper temperature storage. The temperature control failure could affect food spoilage and potentially support pathogen growth.

    Product
    CONWAY CAESAR EMPIRE DRESSING 4/1GAL SUPC/ITEM # 38119K
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0832-2024·2024-02-14

    Galbani Smoked Provalone Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1,375 cases of Galbani Smoked Provalone distributed in Ohio, New York, and Pennsylvania due to improper storage temperatures that could have allowed pathogenic growth.

    Product
    GALBANI SMOKED PROV 3/12# SUPC/ITEM # 19422
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0833-2024·2024-02-14

    Ricotta cheese recalled for improper temperature control

    Greco Sidari's ricotta cheese was not held at appropriate temperatures, which could affect food spoilage and potentially support pathogen growth. The recall affects 1375 cases distributed in OH, NY, and PA.

    Product
    GRANDE RICOTTA SOPRAFFINA 6/3# SUPC/ITEM # 19535
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0855-2024·2024-02-14

    Fresh noodle products recalled for undeclared wheat allergen

    Alfred Louie Inc is recalling Pan Fry and Deep Fry Fresh Noodles due to undeclared wheat allergen from enriched flour sub-ingredients. 550 cases distributed in California are affected.

    Product
    Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40Lb cartons, Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0846-2024·2024-02-14

    Potato Salad Recalled for Improper Temperature Storage During Distribution

    Resers Potato Salad Regular is being recalled due to improper temperature storage during distribution, which could potentially support pathogen growth. Affected cases were distributed to Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    RESERS POTATO SALAD REGULAR 3/8# SUPC/ITEM # 0991C
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0824-2024·2024-02-14

    Auricchio Crema al Reggiano recalled for improper storage temperature

    Greco Sidari is recalling Auricchio Crema al Reggiano cheese because the product was not held at appropriate temperatures, which could allow spoilage and pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.

    Product
    AURICCHIO CREMA AL REGGIANO 4/1.1# SUPC/ITEM # 8927
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0289-2024·2024-02-14

    FDA Recalls Omeza Skin Protectant Gel Due to Manufacturing Deviations

    OMEZA LLC is recalling Omeza Skin Protectant Gel due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 1,210 vials distributed nationwide.

    Product
    Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2024·2024-02-14

    BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues

    BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2024·2024-02-14

    Antibiotic susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2024·2024-02-14

    BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled

    BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.

    Product
    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2024·2024-02-14

    Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion

    Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.

    Product
    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2024·2024-02-14

    Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions

    CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.

    Product
    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1011-2024·2024-02-14

    Lab testing discs recalled for potential antibiotic susceptibility testing failures

    Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2024·2024-02-14

    Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection

    Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.

    Product
    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2024·2024-02-14

    Senographe Pristina X-ray system missing audible exposure termination signal

    GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.

    Product
    Senographe Pristina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2024·2024-02-14

    Antibiotic Susceptibility Test Discs Recalled for Accuracy and QC Failures

    Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2024·2024-02-14

    Patient transportation system wheels may be attracted to MRI magnetic fields

    Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.

    Product
    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2024·2024-02-14

    Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc

    Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2024·2024-02-14

    RX Series Copper Assay Requires Modified Testing Order

    Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.

    Product
    RX Series Copper (Cu) Assay Ref. Number CU2340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2024·2024-02-14

    Philips Spectral CT 7500 software issue causes incorrect image labeling

    Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

    Product
    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2024·2024-02-14

    BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures

    Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2024·2024-02-14

    Surgical hip instruments recalled due to compromised sterility packaging

    Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2024·2024-02-14

    BD Sensi Disc Cefepime antibiotic susceptibility testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.

    Product
    BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2024·2024-02-14

    Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

    Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

    Product
    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2024·2024-02-14

    Globus Medical Cranial Drills recalled for sterility loss and discoloration

    Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.

    Product
    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2024·2024-02-14

    Flow-e Anesthesia System Model 6887900 Cybersecurity Vulnerability Recall

    The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.

    Product
    Flow-e Anesthesia System, model 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2024·2024-02-14

    BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis

    Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2024·2024-02-14

    BD antibiotic susceptibility test discs recalled for possible accuracy failures

    BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2024·2024-02-14

    Orthodontic Latex Elastics Mislabeled as Non-Latex by Manufacturer

    FLEXSelect 5/16" Amber Latex Elastics were labeled as non-latex, creating allergy risk for latex-sensitive patients. Patients with latex allergies should immediately stop using the product.

    Product
    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2024·2024-02-14

    BD Antibiotic Testing Discs Recalled for Accuracy Failures

    Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2024·2024-02-14

    BD BBL Antibiotic Susceptibility Test Discs Recalled for Accuracy Failures

    BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed diagnoses or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2024·2024-02-14

    Globus Medical Cranial Drill recalled for potential sterility compromise

    Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.

    Product
    Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2024·2024-02-14

    Absorbable Surgical Tacks Recalled for Potential Sterility Compromise

    Covidien LP is recalling AbsorbaTack Absorbable Fixation Device 30 due to packaging defects that may compromise product sterility. Fifty-four units were distributed in five states.

    Product
    AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2024·2024-02-14

    Dental amalgam powder may not triturate properly, affecting restoration strength

    Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.

    Product
    Article No. NA6050411, Valiant PhD No. 1 Econo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2024·2024-02-14

    RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall

    RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.

    Product
    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2024·2024-02-14

    BD antibiotic susceptibility testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2024·2024-02-14

    Optima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion

    BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.

    Product
    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant com
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1025-2024·2024-02-14

    Antibiotic susceptibility testing discs recalled for potential accuracy failures

    Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2024·2024-02-14

    BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues

    BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2024·2024-02-14

    Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias

    Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.

    Product
    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2024·2024-02-14

    Prestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher

    BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.

    Product
    The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reduc
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0974-2024·2024-02-14

    Patient Transportation System Recalled for Magnetic Wheel MRI Interference Risk

    Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.

    Product
    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide

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