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 deaths or serious injuries are reported, 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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3676–3700 of 5038

  • SevereFDA (Devices)·Z-1838-2017·2017-04-26

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk

    Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.

    Product
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2017·2017-04-26

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk

    Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills due to a potential for the cutting blade to detach or the drill head to fracture during use.

    Product
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1840-2017·2017-04-26

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment

    Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.

    Product
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2017·2017-04-26

    Philips UNIQ X-ray Systems Recalled for Potential Fire Hazard

    Philips is recalling UNIQ X-ray systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1777-2017·2017-04-19

    Welch Allyn ProBP 2400 Digital Blood Pressure Device Recall

    Welch Allyn is recalling 981 ProBP 2400 digital blood pressure devices due to a defective electrical component that may cause over-voltage battery charging and melting of plastic parts.

    Product
    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Micro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2017·2017-04-19

    Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

    Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.

    Product
    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressu
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-1776-2017·2017-04-19

    Volcano Recalls Refinity Short Tip Rotational IVUS Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examina
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1773-2017·2017-04-19

    Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure

    Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.

    Product
    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

    Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debrideme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1417-2017·2017-04-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Failure to Deliver Therapy

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.

    Product
    HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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, 5P/
    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-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-1508-2017·2017-03-29

    Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk

    Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords could overheat, posing a risk of fire or thermal injury.

    Product
    Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1504-2017·2017-03-29

    Ohmeda Medical Recalls Giraffe OmniBed Infant Incubators Due to Fire Risk

    Ohmeda Medical is recalling Giraffe OmniBed infant incubators and warmers because certain power cords may overheat, posing a risk of fire or thermal injury.

    Product
    Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1515-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic is recalling Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, RE
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1511-2017·2017-03-29

    Ohmeda Infant Warmer System Recalled Due to Overheating Power Cords

    Ohmeda Medical is recalling IWS Infant Warmer Systems because certain power cords may overheat, posing a fire and thermal injury risk.

    Product
    IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They ful
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1510-2017·2017-03-29

    Ohmeda-Ohio CarePlus Incubator Recall Due to Power Cord Overheating Risk

    Ohmeda Medical is recalling CarePlus Incubators because certain power cords may overheat, posing a risk of fire or thermal injury.

    Product
    CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the
    Category
    Medical Device
    Distribution
    Distributed nationwide