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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19551–19575 of 27647

  • HighFDA (Devices)·Z-2303-2017·2017-06-14

    Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk

    Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects

    ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2223-2017·2017-06-14

    Roche Cobas Connection Module Recalled for Vibration and Contamination Risk

    Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.

    Product
    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2242-2017·2017-06-14

    ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks

    ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.

    Product
    Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2239-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect

    ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2250-2017·2017-06-14

    Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect

    Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.

    Product
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2017·2017-06-14

    ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing

    ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.

    Product
    Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2280-2017·2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2017·2017-06-14

    Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2017·2017-06-14

    ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns

    ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.

    Product
    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2249-2017·2017-06-14

    Alphatec Recalls Arsenal Spinal Fixation System Set Screws

    Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.

    Product
    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2017·2017-06-14

    ConvaTec Recalls Rebreather Oxygen Masks Due to Defect

    ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.

    Product
    Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2237-2017·2017-06-14

    ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks

    ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.

    Product
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2230-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect

    ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2235-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns

    ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2263-2017·2017-06-14

    Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2017·2017-06-14

    Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability

    Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.

    Product
    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2247-2017·2017-06-14

    Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect

    Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.

    Product
    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2151-2017·2017-06-07

    Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates

    Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.

    Product
    Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2175-2017·2017-06-07

    Philips NMT Patient Cable Recall for Potential Skin Burn Risk

    Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.

    Product
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2179-2017·2017-06-07

    GE Healthcare Recalls Patient Steps on RFX, Legacy, and Precision 500D Systems

    GE Healthcare is recalling 2,380 patient steps for RFX, Legacy, and Precision 500D systems because they may detach from the table, posing a fall risk.

    Product
    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2017·2017-06-07

    Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect

    Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.

    Product
    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2176-2017·2017-06-07

    AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

    AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

    Product
    AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2017·2017-06-07

    Cardinal Digital Bariatric Scales Recalled Due to Seat Failure Risk

    Cardinal Scale Mfg Co is recalling 975 digital bariatric scales because a seat may fail unexpectedly, posing an injury risk.

    Product
    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide