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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12801–12825 of 13816

  • HighFDA (Devices)·Z-0117-2022·2021-10-20

    Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

    Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

    Product
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2022·2021-10-20

    Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors

    Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.

    Product
    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0086-2022·2021-10-20

    Endoskeleton TCS Interbody System implant engraving may not match pouch labels

    Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.

    Product
    Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0104-2022·2021-10-20

    K2M Surgical Removal Tool Recalled for Missing Pins

    K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.

    Product
    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0112-2022·2021-10-20

    Flower Drill Bit Kit 2.4mm missing AO connect feature

    Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0093-2022·2021-10-20

    Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors

    Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2022·2021-10-20

    Blood Sampling System Recalled for Pressure Shifts and Incorrect Readings

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0080-2022·2021-10-20

    Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

    Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

    Product
    Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0081-2022·2021-10-20

    Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls

    Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.

    Product
    Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the med
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0029-2022·2021-10-13

    Eco-Med Ultrasound Gels and Lotions Recalled for Bacterial Contamination

    Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.

    Product
    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0009-2022·2021-10-13

    Ultrasound gel distributed with medical devices recalled for bacterial contamination

    Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.

    Product
    GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0010-2022·2021-10-13

    FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.

    Product
    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2022·2021-10-13

    Philips Ultrasound Sparq System Recalled Due to Intermittent Shutdown Risk

    Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2022·2021-10-13

    ZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks

    ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.

    Product
    Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2022·2021-10-13

    ZOLL Solex 7 IV Disposable Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2022·2021-10-13

    Flower E-Kit bone fixation kits recalled due to missing surgical component

    Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.

    Product
    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2022·2021-10-13

    Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

    Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2022·2021-10-13

    OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier

    Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.

    Product
    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2022·2021-10-13

    Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging

    Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recall for Potential Leaks

    Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
    Category
    Medical Device
    Distribution
    Distributed nationwide