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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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38926–38950 of 40449

  • HighFDA (Devices)·Z-0806-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2013·2013-02-20

    Philips SureSigns VS2+ Vital Signs Monitor Recall for Screen Lockup

    Philips Healthcare is recalling 3,248 SureSigns VS2+ monitors because the screen may lock up and stop monitoring patients.

    Product
    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2013·2013-02-20

    Richmar Foam Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling foam electrodes where the socket terminal may pull away from the lead wire. The defect poses a risk of electrical shock or injury.

    Product
    Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0805-2013·2013-02-20

    Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue

    Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.

    Product
    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2013·2013-02-20

    Fresenius Liberty Cycler Set Recalled for Leak and Contamination Risk

    Fresenius Medical Care is recalling 5,590 Liberty Cycler Sets due to a small risk of leaks that could contaminate dialysate and cause peritonitis.

    Product
    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2013·2013-02-20

    Remel Lyophilized Growth Supplement Recalled for Microbial Contamination

    Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.

    Product
    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0821-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2013·2013-02-20

    Breg Cold Therapy Units Recalled for Potential Sterility Compromise

    Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.

    Product
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2013·2013-02-20

    Richmar Cloth Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling specific cloth electrodes because the socket terminal may pull away from the lead wire. The defect could cause electrical stimulation issues.

    Product
    Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0823-2013·2013-02-20

    GE Healthcare Recalls CARESCAPE Monitor B650 Patient Monitors

    GE Healthcare is recalling 2,813 CARESCAPE Monitor B650 units due to potential issues. No illnesses or injuries have been reported.

    Product
    GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0817-2013·2013-02-20

    Richmar Foam Electrodes Recalled for Terminal Detachment

    NAImco Inc dba Richmar Inc is recalling foam electrodes because the socket terminal may pull away from the lead wire.

    Product
    Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0654-2013·2013-02-20

    Lockheed Martin Gyrocam Systems Recalled for Laser Safety Non-Compliance

    Lockheed Martin Gyrocam Systems are being recalled because they contain Class IIIb lasers that failed FDA performance standards and were sold without a required variance.

    Product
    Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2013·2013-02-20

    Quidel Recalls Sofia Influenza A+B FIA Kits Due to False Positives

    Quidel is voluntarily recalling specific lots of Sofia Influenza A+B FIA kits because they may produce false positive results, potentially leading to misdiagnosis.

    Product
    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2013·2013-02-20

    Mizuho Orthopedic Table Spar Recall Due to Possible Instability

    Mizuho OSI is recalling 869 orthopedic table spars because a failed epoxy bond could cause the aluminum plug to migrate, potentially compromising table stability.

    Product
    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0804-2013·2013-02-20

    Breg Recalls Sterile Polar Pads Due to Packaging Damage

    Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.

    Product
    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2013·2013-02-20

    GE Healthcare Recalls Dash Port 2 Docking Stations for Communication Failure

    GE Healthcare is recalling Dash Port 2 docking stations because they may stop communicating with the monitor, causing a loss of patient monitoring.

    Product
    GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they fail to transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit 'HI' or 'LO' blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2013·2013-02-20

    Terumo CDI 101 Hematocrit Monitor Recalled for Inaccurate Readings

    Terumo is recalling 622 CDI 101 Hematocrit/Oxygen Saturation Monitoring Systems because software errors cause inaccurate readings of blood and oxygen levels.

    Product
    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0816-2013·2013-02-20

    Richmar Cloth Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling cloth electrodes where the socket terminal may pull away from the lead wire.

    Product
    Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0798-2013·2013-02-20

    Mindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly

    Mindray is recalling 51 DPM Central Monitoring Systems because a software anomaly may display a step pattern instead of a flat line during asystole.

    Product
    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0813-2013·2013-02-20

    GE Healthcare Recalls Dash Patient Monitors Due to Ethernet Controller Issues

    GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors because an intermittent Ethernet controller defect may cause network connectivity issues.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2013·2013-02-20

    Remel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose

    Remel Inc is recalling 23 units of Oxoid Cefoxitin Antimicrobial Susceptibility Discs because the cartridges may contain discs with an insufficient antibiotic dose.

    Product
    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2013·2013-02-20

    Chenica Wheelchairs Recalled for Crash Test Specification Non-Compliance

    Chenica Inc. is recalling 53 Gunnell Rehab Series wheelchairs because they may not meet WC-19 crash testing specifications.

    Product
    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
    Category
    Medical Device
    Distribution
    Distributed nationwide