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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19826–19850 of 27682

  • SevereFDA (Devices)·Z-1575-2017·2017-04-05

    FDA Recalls 170 Sterile Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 170 sterile laparoscopic procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1668-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1497-2017·2017-04-05

    Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk

    Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.

    Product
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1561-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.

    Product
    Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1646-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1580-2017·2017-04-05

    Recall of Regard Open Heart Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1613-2017·2017-04-05

    FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1699-2017·2017-04-05

    Stryker Visum LED Surgical Lighting System Recalled for Mounting Defect

    Stryker is recalling 292 Visum LED Surgical Lighting systems because missing screws and user overloading may cause the equipment to fall.

    Product
    The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 30 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1639-2017·2017-04-05

    Recall of Regard Sterile Lap PK Spohn Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 3,000 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1656-2017·2017-04-05

    Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 249 sterile robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1644-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1581-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 96 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1663-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1658-2017·2017-04-05

    Recall of Spohn Laparoscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 92 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1683-2017·2017-04-05

    National Biological Hand Foot II UVB-138 Phototherapy Devices Recalled for Wiring Defect

    National Biological Corp is recalling seven Hand Foot II, UVB-138 phototherapy devices because wiring defects may allow lamps to turn on with the key switch rather than the timer.

    Product
    Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1624-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 280 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1633-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 71 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1682-2017·2017-04-05

    Hospira Plum 360 Infusion Pump Software Recall for Battery Alarm Defect

    Hospira is recalling 62,847 Plum 360 Infusion Pumps with software version 15.02 due to a defect that causes therapy to stop and incorrect alarms to display.

    Product
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2017·2017-04-05

    FDA Recalls 460 Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 460 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1619-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 356 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1673-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1563-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1697-2017·2017-04-05

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Data Access Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.

    Product
    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2017·2017-04-05

    Recall of Regard Sterile Abdominal Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 210 sterile abdominal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
    Category
    Medical Device
    Distribution
    2 states