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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16601–16625 of 40248

  • ModerateFDA (Devices)·Z-2874-2020·2020-09-02

    Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.

    Product
    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2902-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2886-2020·2020-09-02

    Match Point System surgical instrument recalled due to incorrect procedure side labeling

    The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.

    Product
    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2877-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling

    OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2876-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling

    OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2821-2020·2020-08-26

    Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables

    Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.

    Product
    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2828-2020·2020-08-26

    NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling

    Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.

    Product
    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2020·2020-08-26

    PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery

    Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.

    Product
    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2020·2020-08-26

    DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues

    Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.

    Product
    DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2807-2020·2020-08-26

    Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues

    Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2818-2020·2020-08-26

    Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment

    Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.

    Product
    Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2817-2020·2020-08-26

    Golden Technologies Lift Chair Recalled for Suspected Poor Weld

    Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.

    Product
    Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2806-2020·2020-08-26

    Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets

    Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.

    Product
    ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2814-2020·2020-08-26

    Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton

    Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.

    Product
    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2825-2020·2020-08-26

    CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2826-2020·2020-08-26

    CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2830-2020·2020-08-26

    Pharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads

    Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads because the device was incorrectly registered as a Class I device and requires a 510(k) submission.

    Product
    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2020·2020-08-26

    Chembio DPP Micro Reader Recalled for Performance Issues

    Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2020·2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2809-2020·2020-08-26

    Chembio DPP Micro Reader II Recalled for Performance Issues

    Chembio Diagnostics is recalling 97 DPP Micro Reader II kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2829-2020·2020-08-26

    Cytocell NUP98 Distal Probe Green Recalled for False Positive Risk

    Cytocell Ltd. is recalling NUP98 Distal Probe Green units due to a low risk of false positive results in laboratory testing.

    Product
    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2020·2020-08-26

    CareFusion Alaris PCA Module 8120 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2823-2020·2020-08-26

    CareFusion Alaris Syringe Module LED Display Dimness Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2827-2020·2020-08-26

    Smith & Nephew Recalls Polarstem Collar Reamer Guides Due to Design Issue

    Smith & Nephew is recalling 528 units of the Polarstem Collar Reamer Guide due to a product design issue. The devices were distributed worldwide and in the US.

    Product
    POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208)…
    Category
    Medical Device
    Distribution
    Distributed nationwide