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.

19076–19100 of 50410

  • HighFDA (Devices)·Z-2584-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail Due to Hardware Defect

    The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2611-2021·2021-10-06

    Corin Unity Knee Implant Components Recalled for Packaging Damage Risk

    Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.

    Product
    Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2021·2021-10-06

    Corin Trinity Liner hip implant components recalled due to packaging damage

    Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.

    Product
    Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2547-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk

    B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.

    Product
    60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2021·2021-10-06

    Outlook V1500HP Pump Set Recalled for Cassette Leakage

    The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.

    Product
    V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2021·2021-10-06

    Corin BIOLOX Delta Mod Head hip implant components recall due to packaging damage

    Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.

    Product
    Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2021·2021-10-06

    Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use

    Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.

    Product
    The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2555-2021·2021-10-06

    B. Braun Pump Set Cassette Leakage Risks Medication Delivery

    B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.

    Product
    PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1019-2021·2021-10-06

    Enrico Biscotti Anise Almond Biscotti Recalled for Undeclared Soy

    The Enrico Biscotti Company is recalling Enrico Biscotti Anise Almond Biscotti 8-ounce bags because they contain undeclared soy, a major allergen. The recall affects 3,840 bags distributed to Ohio and New York.

    Product
    Enrico Biscotti - Anise Almond Biscotti 8 ounce bags 6 bags per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2580-2021·2021-10-06

    Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

    Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

    Product
    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2021·2021-10-06

    Arjo Citadel Beds: Power Cord Wear May Cause Electrical Hazard

    Certain Arjo Citadel medical beds with IndiGo power cords may develop wear during normal use, potentially causing electrical short circuits and fire hazards. Units manufactured from May 2018 through February 2021 are affected.

    Product
    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2021·2021-10-06

    Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.

    Product
    Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2550-2021·2021-10-06

    Outlook pump extension sets recalled due to leakage and dosing errors

    Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.

    Product
    ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2021·2021-10-06

    Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated

    Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.

    Product
    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1025-2021·2021-10-06

    De Wafelbakkers Buttermilk Pancakes Recalled for Listeria Contamination

    De Wafelbakkers 18 ct Buttermilk Pancakes are being recalled nationwide because they may contain Listeria monocytogenes. Consumers should not eat the product.

    Product
    De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2021·2021-10-06

    Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss

    Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.

    Product
    Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2021·2021-10-06

    Blood Administration Pump Set Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.

    Product
    Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2021·2021-10-06

    Patient Lift Device Stretch Leveller May Lose Horizontal Position Control

    Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.

    Product
    LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V780000·2021-10-06

    Nexus Recalls 2018-2020 RVs Due to Gas Leak Risk in Stoves

    Nexus is recalling 2018-2020 recreational vehicles because a stove component may cause a gas leak, increasing fire risk.

    Product
    NEXUS — NEXUS EVOQUE, BENTLEY DIAMOND, BENTLEY, WRAITH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2605-2021·2021-10-06

    Corin Trinity-i Acetabular Components Recalled Due to Packaging Damage

    Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.

    Product
    Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2021·2021-10-06

    Cardiosave Rescue IABP may unexpectedly shut down during operation

    Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2021·2021-10-06

    Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance

    Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.

    Product
    BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2021·2021-10-06

    NAMIC Stopcocks Recalled Due to Potential Sterile Barrier Breach

    Medline Industries is recalling NAMIC Stopcocks due to potential sterile barrier breaches from microscopic pinholes in sterile pouches, which could allow non-sterile conditions.

    Product
    NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2021·2021-10-06

    Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk

    B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.

    Product
    OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
    Category
    Medical Device
    Distribution
    Distributed nationwide