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.

44026–44050 of 50511

  • 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 (Food)·F-0972-2013·2013-02-20

    Cheese Mini Turnovers Recalled for Undeclared Milk Allergen

    Suadel Food Products is recalling Estrella Pastelillos de Queso because the common name 'milk' is not declared in the ingredients or 'Contains' statement.

    Product
    "Estrella Food Products, Inc***Pastelillos de Queso (Cheese Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-0973-2013·2013-02-20

    Pizza Mini Turnovers Recalled for Undeclared Milk Allergen

    Suadel Food Products is recalling Estrella Pastelillos de Pizza because the common name 'milk' is not declared in the ingredients or 'Contains' statement.

    Product
    "Estrella Food Products, Inc***Pastelillos de Pizza (Pizza Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-0985-2013·2013-02-20

    Pamela's Baking and Pancake Mix Recalled for Potential Glass or Plastic Fragments

    Pamela's Products, Inc. is recalling 2,229 cases of Baking and Pancake Mix due to complaints that the product may contain glass or plastic fragments.

    Product
    Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0971-2013·2013-02-20

    Estrella Pizza Turnovers Recalled for Undeclared Wheat and Milk Allergens

    Suadel Food Products is recalling Estrella Empanadillas de Pizza due to undeclared wheat and milk. The product was distributed in Puerto Rico.

    Product
    "ESTRELLA***Empanadillas de Pizza" (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-0988-2013·2013-02-20

    Pamela's Peanut Butter Chocolate Chip Cookies Recalled for Glass or Plastic Fragments

    Pamela's Products is recalling specific gluten-free cookies due to complaints about potential glass or plastic fragments.

    Product
    Pamela's Peanut Butter Chocolate Chip Cookies; Gluten Free 5.29 oz. package. UPC 93709-40180 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    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 (Food)·F-0987-2013·2013-02-20

    Pamela's Chocolate Cake Mix Recalled for Potential Glass or Plastic Fragments

    Pamela's Products, Inc. is recalling specific batches of Chocolate Cake Mix due to complaints that the product may contain glass or plastic fragments.

    Product
    Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy 21 oz. package. UPC 93709-30040 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    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