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.

32176–32200 of 50502

  • HighFDA (Devices)·Z-2137-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2017·2017-05-31

    Teleflex Recalls Infant Catheter Connectors Due to Sterility Concerns

    Teleflex Medical is recalling 19,043 units of INFANT 20/BX sterile catheter connectors. The recall was initiated voluntarily due to a lack of reason for recall in the source text.

    Product
    INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2017·2017-05-31

    B. Braun Recalls CytoGuard Closed Luer Connectors Due to Sterility Concerns

    B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors because some blisters may be punctured, compromising the sterility barrier.

    Product
    CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2017·2017-05-31

    CORPAK CORFLO PEG Adaptor Repair Kit Recalled for Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break unexpectedly when exposed to stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2134-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2251-2017·2017-05-31

    U-Can Food Trading Recalls Sugar Crackers for Undeclared Soy

    U-Can Food Trading is recalling Sugar Crackers because they may contain undeclared soy. The recall affects 970 cartons distributed in four US states.

    Product
    Sugar Crackers 400g (14.1oz) x 12 packets per carton/case, UPC 9556184 500023
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2140-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Wound Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt PVC Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2017·2017-05-31

    Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps

    Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2143-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2017·2017-05-31

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures

    Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.

    Product
    SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2017·2017-05-31

    CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe.…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2017·2017-05-31

    Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

    Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2243-2017·2017-05-31

    Rich Products Recalls Pizza Dough Balls Due to E. coli 0121 Risk

    Rich Products Corp is recalling 7 oz pizza dough balls because the flour used may be contaminated with E. coli 0121.

    Product
    7 OZ PIZZA DOUGH BALL, PRODUCT CODE 11267, UPC 0 00 49800 1267 4, NET CASE WT 12.9 KG (28 LB 7 OZ), UNIT NET WT: 198 G (7 OZ), COUNT: 65 --- PROCESSED IN CANADA, DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2147-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2017·2017-05-31

    Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices

    Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.

    Product
    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2244-2017·2017-05-31

    Rich Products Recalls Artisan Crust Pizza Dough Due to E. coli Risk

    Rich Products Corp is recalling Artisan Crust Pizza Dough because the flour used may be contaminated with E. coli O121.

    Product
    ARTISAN CRUST PIZZA DOUGH 24/18, PRODUCT CODE 11413, UPC 1 00 49800 11413 2, NET CASE WT: 27 LB (12.2 KG), UNIT NET WT: 18 OZ (1 LB 2 OZ) (510G), COUNT: 24 --- PROCESSED IN CANADA DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2131-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2017·2017-05-31

    CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under stress.

    Product
    CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a…
    Category
    Medical Device
    Distribution
    3 states