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.

42926–42950 of 50511

  • HighFDA (Devices)·Z-2065-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2064-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2074-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2068-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2061-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2080-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2114-2013·2013-09-04

    Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure

    Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.

    Product
    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2013·2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure

    Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2013·2013-09-04

    GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2013·2013-09-04

    Integra Leyla Ball Joint Clamp Recalled for Potential Instability

    Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.

    Product
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open…
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2098-2013·2013-09-04

    GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations

    GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.

    Product
    GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2054-2013·2013-09-04

    Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant

    Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.

    Product
    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2013·2013-09-04

    Respironics V1000 Ventilator Recalled Due to Display Backlight Interruption

    Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.

    Product
    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·13V400000·2013-09-04

    Winnebago Recalls 2013-2014 Motorhomes Due to Child Seat Tether Defect

    Winnebago is recalling 2013-2014 Aspect and Itasca Cambria motorhomes because the child seat tether is mounted improperly, which may fail to protect occupants in a crash.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA ASPECT, CAMBRIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V399000·2013-09-04

    Aliner Travel Trailer Recall for Door Lock Jamming Risk

    Columbia Northwest is recalling 2006-2013 Aliner travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    ALINER — ALINER TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2013·2013-09-04

    GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise

    GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2013·2013-09-04

    Roche Recalls ACCU-CHEK FastClix Lancing Devices Due to Needle Retraction Defect

    Roche Diagnostics is recalling 36,332 ACCU-CHEK FastClix Lancing Devices because the needle may not fully retract after use, posing a puncture risk.

    Product
    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling nine trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1855.2013·2013-09-04

    Quesos Vaca Negra cheese recalled for E. coli test results

    Quesos Vaca Negra, Inc. is recalling specific cheese wheels in Puerto Rico after positive test results for generic E. coli.

    Product
    "***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2105-2013·2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2076-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-926-2013·2013-09-04

    Hospira Recalls Ketorolac Tromethamine Injections Due to Sterility Concerns

    Hospira, Inc. is recalling 345,800 vials of Ketorolac Tromethamine Injection due to a lack of assurance of sterility caused by loose or missing crimps on fliptop vials.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    0 states