The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11426–11450 of 53044

  • HighFDA (Devices)·Z-2654-2023·2023-10-11

    EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations

    A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.

    Product
    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2024·2023-10-11

    API3200MD Mass Spectrometer Recalled for Potential Fire Risk

    AB Sciex is recalling three API3200MD mass spectrometers due to a rare risk of fire and electrode ejection from a solvent leak combined with electrical discharge. The flame could cause injury to users or property damage.

    Product
    API3200MD Mass Spectrometer, Part Number 4466230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2024·2023-10-11

    BD Cathena IV Catheter Safety Shield May Fail to Properly Engage

    Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.

    Product
    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0025-2024·2023-10-11

    Fentanyl injectable syringes recalled nationwide for sterility assurance failure

    Fentanyl 1,250 mcg/25 mL syringes from Central Admixture Pharmacy Services Inc are being recalled nationwide due to lack of assurance of sterility. The manufacturer could not confirm that affected lots meet required sterility standards.

    Product
    fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0003-2024·2023-10-11

    Ephedrine Injectable Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2024·2023-10-11

    Fentanyl in Dextrose Syringes Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.

    Product
    fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0002-2024·2023-10-11

    Ketamine syringes recalled for lack of sterility assurance

    CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2023·2023-10-11

    Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms

    Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.

    Product
    EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2023·2023-10-11

    Apellis Injection Kit Filter Needles Recalled for Structural Defects

    Apellis Pharmaceuticals is recalling 61,943 units of Injection Kit components due to structural variations in the 19-gauge filter needle. No causal relationship has been established between the defect and the rare adverse events observed.

    Product
    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0001-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling 1,762 fentanyl syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2023·2023-10-11

    Cuff Pressure Manager Power Inlet Dislodgment Prevents Charging

    The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.

    Product
    Puritan Bennett Cuff Pressure Manager, REF: 180-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2660-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Manufacturing Non-conformance

    Olympus is recalling Veran endobronchial navigation devices (6,484 units) worldwide due to manufacturing non-conformances and insufficient evidence of adequate electromagnetic compatibility. The devices may not function acceptably in environments with electromagnetic interference.

    Product
    Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0041-2024·2023-10-11

    Drug Recall: Triamcinolone Acetonide Injectable Contains Glass Contamination

    Eugia US LLC is recalling 1,626 vials of Triamcinolone Acetonide Injectable Suspension due to glass contamination. The affected lot (3TC22010, exp. 11/30/2024) was distributed nationwide.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0028-2024·2023-10-11

    HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.

    Product
    HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2024·2023-10-11

    Guide Catheter Recalled for Incorrect Tip Curve Shape

    Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.

    Product
    Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2023·2023-10-11

    Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance

    Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.

    Product
    Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.

    Product
    Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2024·2023-10-11

    Drug eye drops recalled for manufacturing practice deviations nationwide

    Dr. Berne's Organic Castor Oil Eye Drops are being recalled due to manufacturing practice deviations. The voluntary recall affects 1,744 bottles distributed nationally and internationally.

    Product
    Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], Certified Organic by Organic Certifiers.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2024·2023-10-11

    Cardiac guide catheters recalled for incorrect tip curve

    Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2649-2023·2023-10-11

    Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly

    Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.

    Product
    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0019-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue

    Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0040-2024·2023-10-11

    FDA Recalls Subpotent Epinephrine Injectable for Intraocular Surgical Use

    Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.

    Product
    Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0022-2024·2023-10-11

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
    Category
    Drug
    Distribution
    Distributed nationwide