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.

31951–31975 of 50502

  • HighFDA (Devices)·Z-2347-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Streptococcus Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2017·2017-06-21

    GE Healthcare Discovery IQ X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling Discovery IQ X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery IQ X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2017·2017-06-21

    Cook Inc. Recalls Pereyra Ligature Carrier 75 Due to Reprocessing Instructions

    Cook Inc. is recalling 29 Pereyra Ligature Carrier 75 devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Pereyra Ligature Carrier 75
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2361-2017·2017-06-21

    Bright Farms Baby Kale Recalled Due to Metal Contamination

    Bright Farms is recalling Baby Kale packages due to detected metal. The firm identified the issue through internal verification.

    Product
    Bright Farms Baby Kale 3 oz. package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2356-2017·2017-06-21

    Bright Farms Basil Recalled Due to Metal Contamination

    Bright Farms is recalling basil packages due to detected metal. The firm identified the issue through internal verification and believes there is a health hazard.

    Product
    Bright Farms Basil (.75 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2193-2017·2017-06-21

    GE Healthcare Discovery ML X-ray System Recalled for Scan Timing Defect

    GE Healthcare is recalling 10,884 Discovery ML X-ray systems because a defect may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery Ml X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2017·2017-06-21

    Pentax Video Nasopharyngolaryngoscopes Recalled for Loose Suction Arms

    Pentax of America Inc is recalling 1,701 Video Nasopharyngolaryngoscopes due to loose suction arms. The action documents corrective measures taken in 2010-2011.

    Product
    Video Naso pharyngo Laryngoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2017·2017-06-21

    Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect

    Medtronic is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.

    Product
    SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 100 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2409-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N236), REF 413171, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2017·2017-06-21

    GE Healthcare LightSpeed VCT X-ray System Recalled for Scan Timing Defect

    GE Healthcare is recalling 10,884 LightSpeed VCT X-ray systems because a defect may cause scans to start before the prescribed delay completes.

    Product
    GE Healthcare LightSpeed VCT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2017·2017-06-21

    GE Healthcare Discovery NM/CT 670 CZT X-ray System Recall

    GE Healthcare is recalling Discovery NM/CT 670 CZT X-ray systems because a defect may cause scans to start before the prescribed delay completes.

    Product
    GE Healthcare Discovery NM/CT 670 CZT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2360-2017·2017-06-21

    Bright Farms Arugula Recalled Due to Metal Contamination

    Bright Farms is recalling specific lots of arugula because metal was detected in the product. The firm believes this presents a health hazard.

    Product
    Bright Farms Arugula (4 oz. and 8 oz. package) (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2370-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N328), IVD, REF 418630, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2364-2017·2017-06-21

    Bright Farms Mixed Greens Recalled Due to Metal Contamination

    Bright Farms is recalling Mixed Greens 4oz packages because metal was detected in the product. The firm believes there is a risk of a health hazard.

    Product
    Bright Farms Mixed Greens 4oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2533-2017·2017-06-21

    Applied Medical Recalls Kii Trocars Due to Sterilization Concerns

    Applied Medical Resources Corp is recalling specific Kii trocars due to the possibility of insufficient sterilization. The recall affects 7,939 units distributed in the US and worldwide.

    Product
    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2543-2017·2017-06-21

    Medtronic Recalls Endo Stitch Polysorb Sutures Due to Seal Defect

    Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the material to degrade prematurely.

    Product
    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2362-2017·2017-06-21

    Bright Farms Thai Basil Recalled Due to Metal Contamination

    Bright Farms is recalling Thai Basil packages due to detected metal contamination. The firm identified the issue through internal verification.

    Product
    Bright Farms Thai Basil 0.75oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states