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.

40501–40525 of 50511

  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2425-2014·2014-09-17

    Marjon Alfalfa Sprouts Recalled Due to Listeria Contamination Risk

    Marjon Specialty Foods is recalling Marjon Alfalfa Sprouts because environmental samples in the production area tested positive for Listeria.

    Product
    Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2600-2014·2014-09-17

    Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 9 units of CLAW 3.5mm plates because they were manufactured from an incorrect raw material.

    Product
    CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2014·2014-09-17

    Life Force Chamber Recalled for Lack of FDA Approval

    Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.

    Product
    Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2014·2014-09-17

    Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure

    Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.

    Product
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2432-2014·2014-09-17

    Hy-Top French Onion Dip Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Hy-Top French Onion Dip because a supplier used wheat instead of whey in the cheese premix.

    Product
    HY-TOP FRENCH ONION DIP; NET WT 9 OZ. (255g); DISTRIBUTED BY FEDERATED GROUP, INC.; ARLINGTON HEIGHTS IL. 60005-1096. Shipped in cases of 12/9 oz containers.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2615-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V558000·2014-09-12

    Halcore Recalls 2014 Horton Ambulances with Liquid Spring Suspension Kits

    Halcore is recalling 29 model year 2014 Horton ambulances equipped with Liquid Spring aftermarket suspension kits because the fluid tank mounting bracket may fail.

    Product
    HORTON AMBULANCE — HORTON AMBULANCE 623, 457, 403, 603
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V561000·2014-09-12

    Jayco Recalls 2015 Jay Flight Trailers Due to Ladder Mounting Defect

    Jayco is recalling 2015 Jay Flight 19RD trailers because the roof ladder may be installed on the wrong side without proper support, increasing injury risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14275·2014-09-11

    Kidde Recalls Hard-Wired Smoke and Combination Smoke/CO Alarms Due to Failure

    Kidde is recalling about 1.3 million hard-wired smoke and combination smoke/CO alarms because they may fail to alert users during a power outage. No injuries have been reported.

    Product
    Kidde hard-wired smoke and combination smoke/carbon monoxide (CO) alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V556000·2014-09-11

    Toyota Recalls 2014 Tundra CrewMax and Double Cab for Air Bag Defect

    Toyota is recalling 2014 Tundra CrewMax and Double Cab vehicles because a B-pillar trim misinstallation may prevent side air bags from deploying properly in a crash.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V553000·2014-09-11

    Mack Trucks Recalls 2015 Models Due to Seat Belt Bolt Torque Defect

    Mack Trucks is recalling 2015 CHU, CXU, and GU trucks because seat belt bolts may not be torqued correctly, risking detachment in a crash.

    Product
    MACK — MACK GRANITE (GU), CHU, PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V557000·2014-09-11

    Volvo Recalls 2015 VNL and VNX Trucks for Engine Stall Risk

    Volvo is recalling 2015 VNL and VNX trucks because a software error may cause the engine to stall while driving, increasing crash risk.

    Product
    VOLVO — VOLVO VNL, VNX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2014·2014-09-10

    Spacelabs Ariatele Telemetry Transmitter Recalled for SpO2 Display Errors

    Spacelabs is recalling Ariatele Telemetry Transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V551000·2014-09-10

    Mack Recalls 2015 Titan Trucks Due to Engine Stall Risk

    Mack Trucks is recalling 2015 Titan trucks because a software error may cause the engine to stall, increasing crash risk.

    Product
    MACK — MACK TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage

    Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2014·2014-09-10

    Hill-Rom Affinity Four Birthing Bed Recall for Latch Mechanism Defect

    Hill-Rom is recalling 13,000 Affinity Four Birthing Beds because the attachment latch mechanism can bend, potentially causing the foot section to fail and resulting in user injury from a fall.

    Product
    Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2406-2014·2014-09-10

    GoMacro Recalls MACROBAR Bars for Potential Salmonella Contamination

    GoMacro is recalling specific lots of MACROBAR sunflower butter + chocolate and almond butter + carob bars due to potential Salmonella contamination.

    Product
    gomacro MACROBAR brand sunflower butter + chocolate Net Wt. 2.3 oz (65 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2014·2014-09-10

    Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

    Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

    Product
    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J…
    Category
    Medical Device
    Distribution
    Distributed nationwide