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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39551–39575 of 40480

  • ModerateFDA (Devices)·Z-0193-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls

    Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack hematology controls due to customer reports of inaccurate MCV and RDW% values.

    Product
    Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2013·2012-11-14

    Zimmer Recalls Mueller Low Profile Cups Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for Mueller Low Profile Cups manufactured before March 2010 due to reference and lot number discrepancies.

    Product
    Original M.E. Mueller" Low Profile Cup Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2013·2012-11-14

    Sunquest Laboratory Version 7.0 Recalled for Data Integrity Errors

    Sunquest Information Systems is recalling Sunquest Laboratory version 7.0 because a software defect can cause user-defined data to be incorrectly replaced.

    Product
    Sunquest Laboratory, version 7.0 not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2013·2012-11-14

    Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2013·2012-11-14

    Zimmer Recalls Wagner SL Revision Stems for Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Wagner SL Revision Stems due to discrepancies in reference and lot numbers.

    Product
    Wagner SL Revision Stem, uncemented Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2013·2012-11-14

    Zimmer Recalls Distal Centralizers Due to Labeling Discrepancy Complaints

    Zimmer Inc. is correcting patient labels for MS-30 Distal Centralizers manufactured before March 2010 after receiving four complaints regarding reference and lot number discrepancies.

    Product
    MS-30¿ Distal centralizer, cemented, sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0261-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.

    Product
    R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0206-2013·2012-11-14

    Philips Recalls Pinnacle3 Virtual Client Connection Software Due to Improper Release

    Philips Medical Systems is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and distribution.

    Product
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0210-2013·2012-11-14

    Zimmer Recalls Alloclassic SL Shafts for Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Alloclassic SL Shafts manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Alloclassic SL Shaft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2013·2012-11-14

    Zimmer Recalls BioloX Option Ceramic Femoral Heads Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for BioloX Option Ceramic Femoral Head Systems manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Biolox¿ Option Ceramic Femoral Head System Rx, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0234-2013·2012-11-14

    Zimmer Recalls 18 CLS Stem Implants Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for 18 CLS Stem implants manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    CLS Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2013·2012-11-14

    Sysmex XE-2100C Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.

    Product
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0214-2013·2012-11-14

    Alloclassic SL-Offset Stem Patient Labels Corrected for Number Discrepancies

    Zimmer is correcting patient labels on 126 Alloclassic SL-Offset Stems made before March 2010 after four complaints that their reference and lot numbers differed from the correct product labels.

    Product
    Alloclassic¿ SL-Offset Stem sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0221-2013·2012-11-14

    Zimmer Recalls Wagner Cone Prostheses Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for Wagner cone prostheses manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Wagner cone Prosthesis, uncemented, sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0242-2013·2012-11-14

    Zimmer Recalls Dynesys Pedicle Screws Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys Top-Loading System Cannulated Pedicle + Set Screws manufactured before March 2010 due to discrepancies between product and patient labels.

    Product
    Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0191-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.

    Product
    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-0224-2013·2012-11-14

    Zimmer Recalls Anatomical Shoulder Fracture Humeral Stems for Label Discrepancies

    Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding reference and lot numbers.

    Product
    Anatomical Shoulder" Fracture Humeral stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0220-2013·2012-11-14

    Zimmer Fitmore Hip Stem Label Correction for Reference and Lot Discrepancies

    Zimmer Inc. is correcting patient labels for Fitmore Hip Stems manufactured before March 2010 due to discrepancies between product and patient labels regarding reference and lot numbers.

    Product
    Fitmore" Hip Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0225-2013·2012-11-14

    Zimmer Anatomical Shoulder Humeral Head Label Correction

    Zimmer, Inc. is correcting patient labels for Anatomical Shoulder Humeral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Humeral Head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0223-2013·2012-11-14

    Zimmer Anatomical Shoulder Humeral Stem Label Correction

    Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems due to discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Humeral stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0190-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.

    Product
    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-0253-2013·2012-11-14

    Siemens Dimension Vista Homocysteine Reagent Cartridges Recalled for Leaking

    Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.

    Product
    Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0215-2013·2012-11-14

    Zimmer Recalls Metasul LDH Head Due to Patient Label Discrepancies

    Zimmer, Inc. is correcting patient labels for Metasul LDH Head Rx Sterile products manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Metasul¿ LDH¿ Head Rx Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide