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.

13801–13825 of 22165

  • HighCPSC·24702·2023-10-12

    YourHealthToolkit Children's Weighted Blankets Recalled for Asphyxiation Hazard

    YourHealthToolkit is recalling about 280 children's 5-pound weighted blankets sold on Amazon.com from January through March 2020. A young child can become entrapped inside the blanket by unzipping it, posing a risk of death by asphyxiation.

    Product
    YourHealthToolkit 5-pound children's weighted blankets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V947000·2023-10-12

    2022 RAM PROMASTER recalled for inoperative rearview camera

    Chrysler recalls 2022 RAM PROMASTER vehicles with an incorrect rearview camera that cannot be installed, reducing rear visibility and increasing crash risk.

    Product
    RAM — 2022 RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V949000·2023-10-12

    2021-2023 Holiday Rambler and Fleetwood Motorhomes: Propane Tank Valve Defect

    REV Recreation Group is recalling certain 2021-2023 Holiday Rambler and Fleetwood motorhomes due to service valve defects on LPG tanks that may cause propane leaks and fire risk. Dealers will replace valves at no cost.

    Product
    HOLIDAY RAMBLER — 2021 HOLIDAY RAMBLER NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V951000·2023-10-12

    Motorhomes recalled for faulty LPG service valves causing propane leak risk

    Kibbi is recalling 2022–2023 Renegade Valencia motorhomes. Service valves on LPG tanks may be improperly connected, creating a propane leak risk that could lead to fire if an ignition source is present.

    Product
    RENEGADE — 2023 RENEGADE VALENCIA
    Category
    Vehicle
    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 (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 (Drugs)·D-0007-2024·2023-10-11

    Phenylephrine Injectable Syringes Recalled for Sterility Assurance

    Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    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 (Devices)·Z-2658-2023·2023-10-11

    HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect

    The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.

    Product
    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
    Category
    Medical Device
    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-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-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-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
  • HighNHTSA·23V761000·2023-10-11

    Prevost Motor Coaches Recalled for Fire Risk in Grid Heater System

    Prevost Car (US) Inc. is recalling 204 certain 2023-2024 H3-45 and X3-45 VIP motor coaches due to loose grid heater cable connections that can cause the relay to overheat, increasing fire risk.

    Product
    PREVOST — 2023 PREVOST H3-45 VIP
    Category
    Vehicle
    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-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 (Devices)·Z-2666-2023·2023-10-11

    Siemens ADVIA Chemistry Iron_2 Reagents Recalled for Potential Measurement Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Iron_2 Reagents due to a potential positive bias in test results that could affect the accuracy of Quality Control and patient iron level measurements.

    Product
    ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
    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 (Food)·F-0001-2024·2023-10-11

    Vive Organic Wellness Shot Recalled for Undeclared Coconut Allergen

    Vive Organic is recalling its Detox + Immunity wellness shots for undeclared coconut allergen. The product was distributed to retailers across 16 U.S. states.

    Product
    2 oz VIVE ORGANIC DETOX + IMMUNITY KIWI APPLE SUPERGREENS WELLNESS SHOT; Total package size: 12 bottles per case; Storage instructions: Keep Refrigerated; Date(s) of manufacture: 06/29/23 - 06/30/23
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2664-2023·2023-10-11

    Veran Endobronchial Navigation System: Manufacturing and EMC Defects

    Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.

    Product
    Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2024·2023-10-11

    Zimmer Dermatome Blades recalled for producing thin, non-uniform skin grafts

    Zimmer Surgical is recalling dermatome blades that produce thin, non-uniform skin grafts during surgical use. The defect may require additional surgical harvests to adequately cover grafting sites.

    Product
    Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
    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 (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 (Devices)·Z-2665-2023·2023-10-11

    Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results

    Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.

    Product
    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    Distributed nationwide