The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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34476–34500 of 40325

  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use.…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2015·2014-11-12

    Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece

    Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.

    Product
    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2015·2014-11-12

    Merit Maestro Microcatheter Recalled for Incorrect Distal Tip Size

    Merit Medical Systems is recalling 56 Maestro Microcatheters because they were packaged with a 2.8 F distal tip instead of the labeled 2.4 F.

    Product
    Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2015·2014-11-12

    Siemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays

    Siemens Healthcare Diagnostics is recalling Calibrator E kits due to positive bias in Cortisol and Progesterone assays on ADVIA Centaur Systems.

    Product
    Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0096-2015·2014-11-05

    Hospira Recalls GemStar Power Supply Due to Power Delivery Failure

    Hospira is recalling GemStar Power Supplies because they may fail to provide direct current power to the infusion pump, potentially causing smoke.

    Product
    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-0095-2015·2014-11-05

    Hospira Recalls GemStar Power Supplies Due to Power Delivery Failure

    Hospira is recalling 978 GemStar Power Supplies because they may fail to provide power to the infusion pump, resulting in smoke.

    Product
    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-0142-2015·2014-11-05

    Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk

    Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.

    Product
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0151-2015·2014-11-05

    Joerns EasyCare Bed Recalled Due to Care-Lock Feature Failure Risk

    Joerns Healthcare is recalling 3,135 EasyCare Beds because the Care-Lock feature may fail to stay engaged, posing a safety risk to patients.

    Product
    Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2015·2014-11-05

    Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue with Ferritin Analytical Sensitivity. The recall affects 234 kits distributed worldwide.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2015·2014-11-05

    Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data

    Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.

    Product
    Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2015·2014-11-05

    Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

    Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

    Product
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2015·2014-11-05

    Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias

    Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.

    Product
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2015·2014-11-05

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling five lots of Monoswift PGCL absorbable surgical sutures because they failed to meet minimum tensile strength requirements over their shelf life.

    Product
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0020-2015·2014-11-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.

    Product
    Proteus 235 Proton Therapy System for cancer treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2015·2014-11-05

    SAM Medical Products Recalls Junctional Tourniquet Auxiliary Straps

    Sam Medical Products is recalling SJT 102 and 112 auxiliary straps because the snap hook broke during a training demonstration.

    Product
    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2015·2014-11-05

    Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects

    Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.

    Product
    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2015·2014-11-05

    Medartis Recalls APTUS Ulna Shortening 2.5 Plates Due to Breakage

    Medartis, Inc. is recalling 44 APTUS Ulna Shortening 2.5 plates due to three complaints of temporary tension bolt breakage.

    Product
    APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2015·2014-11-05

    Trumpf TITAN Operating Room Table Recalled for Unintended Movement

    Trumpf Medical Systems is recalling 184 TITAN Operating Room Tables due to unintended movement during surgery caused by damaged remotes.

    Product
    TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2015·2014-11-05

    Siemens ADVIA Centaur Calibrator C Recalled for Ferritin Assay Sensitivity Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue affecting ferritin assay sensitivity.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide