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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21801–21825 of 27699

  • HighFDA (Devices)·Z-1514-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.

    Product
    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1499-2016·2016-04-27

    Leica Surgical Microscopes Recalled for Potential Overheating and Smoke

    Leica Microsystems is recalling 381 M525 and M720 surgical microscopes because an electronic component may overheat, causing smoke and smell.

    Product
    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2016·2016-04-27

    Coloplast Recalls Pediatric Catheters Due to Missing Eyelets

    Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.

    Product
    Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling four units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1453-2016·2016-04-20

    Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues

    Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1335-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1339-2016·2016-04-20

    Dexcom G5 Mobile Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 41,925 G5 Mobile Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2016·2016-04-20

    Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1337-2016·2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers with Share because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1422-2016·2016-04-20

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1334-2016·2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1393-2016·2016-04-20

    RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk

    RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.

    Product
    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1336-2016·2016-04-20

    Dexcom G4 PLATINUM Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM receivers because they may fail to provide intended audible alarms or alerts for diabetes patients.

    Product
    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1338-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 19,586 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2016·2016-04-20

    Customed Dressing Change Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1440-2016·2016-04-20

    Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues

    Customed, Inc. is recalling 20 liver and pancreas surgery kits due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2016·2016-04-20

    Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 304 Obstetrical Surgical Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1459-2016·2016-04-20

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1415-2016·2016-04-20

    Customed Wound Manage II Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling Wound Manage II kits due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1479-2016·2016-04-20

    Customed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1427-2016·2016-04-20

    Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 12 units of D&C Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1443-2016·2016-04-20

    Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1399-2016·2016-04-20

    Customed OB Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 32 OB Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1477-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 10 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state