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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13526–13550 of 13802

  • HighFDA (Devices)·Z-1971-2021·2021-07-07

    Tripolar Hooked Stimulation Probes recalled for ethylene oxide sterilization deviation

    Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.

    Product
    Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1977-2021·2021-07-07

    Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk

    Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.

    Product
    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2021·2021-07-07

    Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior

    Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.

    Product
    Synaptive Trackable Suction Set Standard and Malleable
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1997-2021·2021-07-07

    Tempus Pro Patient Monitor Software Error Risk When Unplugged

    Remote Diagnostic Technologies is recalling Tempus Pro patient monitors (Trizeps 7 variant) that can produce error states when unplugged while connected to a specified laryngoscope device. No injuries have been reported.

    Product
    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2021·2021-07-07

    Monitor bracket assembly recalled for detachment hazard on CT imaging systems

    Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and serious injury.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brillia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2021·2021-07-07

    Edwards VAMP Jr. blood management system pressure tubing may detach

    Edwards Lifesciences is recalling 1,679 units of Edwards VAMP Jr. 6 in blood management systems (lot 63445142, 63630816) due to potential pressure tubing detachment.

    Product
    Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1970-2021·2021-07-07

    SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations

    Spes Medica has recalled SNS Disposable Urethral Catheter Electrodes due to possible deviations in ethylene oxide sterilization processes. The recall affects one lot distributed in California, Massachusetts, and South Carolina.

    Product
    SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1960-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall

    Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.

    Product
    Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-1967-2021·2021-07-07

    Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1863-2021·2021-06-30

    Nitric Oxide Delivery System Dosing Deficiency During Console Transitions

    GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.

    Product
    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2021·2021-06-30

    Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.

    Product
    6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1924-2021·2021-06-30

    Ultrasonic Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2021·2021-06-30

    Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.

    Product
    6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1918-2021·2021-06-30

    Hays Ultrasound Kit Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Hays Ultrasound kit Item ID: H1000SE
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1940-2021·2021-06-30

    OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.

    Product
    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2021·2021-06-30

    reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access

    Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.

    Product
    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1939-2021·2021-06-30

    OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.

    Product
    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2021·2021-06-30

    LEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage

    Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.

    Product
    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2021·2021-06-30

    Sterile Colorectal Anoscopes and Proctoscopes Recalled Due to Falsified Sterilization Records

    Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.

    Product
    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1914-2021·2021-06-30

    Ultrasonic Probe Covers Lack FDA Clearance for Body Use

    Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1941-2021·2021-06-30

    OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.

    Product
    OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2021·2021-06-30

    Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.

    Product
    Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1950-2021·2021-06-30

    Econocare Plus Waffle Overlay Recalled for Bodily Fluid Contamination

    EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.

    Product
    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2021·2021-06-30

    Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.

    Product
    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
    Category
    Medical Device
    Distribution
    5 states