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.

11376–11400 of 53044

  • HighFDA (Drugs)·D-0030-2024·2023-10-11

    Hydromorphone Syringe Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.

    Product
    HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2024·2023-10-11

    Citrine QTRAP Mass Spectrometer Recalled for Flammable Solvent Fire Hazard

    AB Sciex is recalling ten Citrine QTRAP Mass Spectrometer units due to potential flame and electrode ejection from flammable solvent leaks combined with electrical discharge.

    Product
    Citrine QTRAP Mass Spectrometer, Part Number 5063685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2023·2023-10-11

    Philips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues

    Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.

    Product
    Incisive CT, software version 5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0026-2024·2023-10-11

    Injectable Succinylcholine Syringes Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services Inc is recalling 3,590 succinylcholine 200 mg/10 mL syringes distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0012-2024·2023-10-11

    Fentanyl injectable product recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.

    Product
    fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2024·2023-10-11

    Medical Convenience Kit Recalled for Defective Dermatome Blades

    ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.

    Product
    GS0008 2Y - Burn Pack - STL, Item Number 880082025
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0027-2024·2023-10-11

    FDA recalls HYDROmorphone injectable syringes for sterility assurance defect

    The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2024·2023-10-11

    Bard Marquee Core Biopsy Kit recalled for needle-cannula diameter mismatch

    Bard Peripheral Vascular is recalling 1,545 Bard Marquee biopsy kits because of a diameter mismatch between the biopsy needle and coaxial cannula. This defect may prevent proper tissue access during procedures and lead to complications including bleeding and pneumotharax.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0006-2024·2023-10-11

    Phenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.

    Product
    PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2023·2023-10-11

    Medical Navigation System Recalled for Manufacturing and Electromagnetic Compatibility Defects

    Olympus Veran percutaneous navigation systems are recalled due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence, affecting approximately 9,961 units distributed worldwide.

    Product
    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0015-2024·2023-10-11

    Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect

    Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses nationwide.

    Product
    fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0021-2024·2023-10-11

    FDA Recalls Fentanyl Injectable Syringes Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1701-2023·2023-10-11

    Sweet and Spicy BBQ Sauce Recalled for Missing Fish Allergen

    The Fresh Chile Company is recalling Sweet and Spicy BBQ sauce because its label failed to declare fish (anchovies) as an allergen. Consumers with fish allergies could face a serious allergic reaction if they unknowingly consume this product.

    Product
    Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Hot. 16 fluid ounce glass jar 19 fl oz. (510g) , with a metal screw top lid.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0031-2024·2023-10-11

    FDA Recalls Hydromorphone Syringes Over Sterility Assurance Issue

    Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.

    Product
    HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0002-2024·2023-10-11

    JLM Roasted Salted Pecan Halves Recalled Due to Hazelnut Substitution

    Lipari Foods is recalling JLM Roasted Salted Pecan Halves because the product contains hazelnuts instead of pecans, presenting a risk to consumers with tree nut allergies.

    Product
    JLM Roasted Salted Pecan Halves, 10oz clear plastic container, 12 per wholesale case. Lipari number 368729, UPC 094776110049
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0020-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.

    Product
    fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2656-2023·2023-10-11

    GE F2-01 Frame Patient Monitor Communication Interruption Risk

    GE F2-01 Frame physiological patient monitors may experience data communication interruptions with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors if not powered down within 120 days.

    Product
    F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0016-2024·2023-10-11

    FDA Recalls Injectable Fentanyl-Bupivacaine Mixture for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling fentanyl-bupivacaine injectables due to lack of assurance of sterility. The recalled 250 mL bags were distributed nationwide.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2024·2023-10-11

    Guider Softip Guide Catheters recalled for incorrect tip curve shape

    Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0023-2024·2023-10-11

    FDA Recalls Fentanyl Injectable for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).

    Product
    fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2024·2023-10-11

    Fentanyl Injectable Solution Recalled for Sterility Assurance Defect

    Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.

    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: 71286-2071-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2024·2023-10-11

    Meera Mobile Operating Table May Move Unexpectedly During Surgery

    Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.

    Product
    Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2024·2023-10-11

    Guider Softip Guide Catheter with Incorrect Tip Curve Shape

    Boston Scientific is recalling Guider Softip Guide Catheters due to an incorrect tip curve shape that differs from the labeled specification. The affected units may not perform as intended during cardiac procedures.

    Product
    Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Design Non-Conformance and EMC Issues

    Olympus Corporation recalls Veran endobronchial navigation devices due to manufacturing non-conformances and insufficient electromagnetic compatibility. Approximately 6,318 units distributed worldwide are affected.

    Product
    Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0008-2024·2023-10-11

    FDA Recalls Rocuronium Syringes Due to Sterility Assurance Issue

    The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been distributed nationwide.

    Product
    rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
    Category
    Drug
    Distribution
    Distributed nationwide