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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16151–16175 of 27500

  • HighFDA (Devices)·Z-1059-2019·2019-04-03

    Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use

    Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.

    Product
    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1047-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2019·2019-04-03

    Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate

    Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2019·2019-04-03

    Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2019·2019-04-03

    Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure

    COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.

    Product
    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1031-2019·2019-03-27

    CTL Medical Hex Driver Recall Due to Anti-Toggle Ring Separation Risk

    CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.

    Product
    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1030-2019·2019-03-27

    CTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk

    CTL Medical is recalling 133 Hex Drivers because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.

    Product
    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1039-2019·2019-03-27

    Shimadzu Mobile X-Ray System Recalled for Brake Failure

    Shimadzu is recalling 93 MobileDaRt Evolution mobile X-ray systems because the brakes may fail to engage when the operator releases the drive handle.

    Product
    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2019·2019-03-27

    Fujifilm FDR Go PLUS Mobile X-Ray System Recalled for Braking Defect

    Fujifilm is recalling 56 mobile X-ray systems because the braking mechanism may fail to engage when the handle is released.

    Product
    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2019·2019-03-27

    ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach

    ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.

    Product
    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2019·2019-03-27

    AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts

    AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.

    Product
    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2019·2019-03-27

    ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk

    ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.

    Product
    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2019·2019-03-27

    CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise

    CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.

    Product
    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2019·2019-03-27

    FDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices

    The FDA is recalling 850 units of the Covidien Force TriVerse electrosurgical device due to potential sterile packaging compromise.

    Product
    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2019·2019-03-20

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.

    Product
    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1006-2019·2019-03-20

    FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch

    Zimmer Trabecular Metal Technology is recalling 26 units of NexGen Trabecular Metal Tibial Half Block Augments because the product in the box may not match the label.

    Product
    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2019·2019-03-20

    Durex Pleasure Pack Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser is recalling Durex Pleasure Pack condoms because five batches failed burst pressure specifications.

    Product
    Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2019·2019-03-20

    Durex Real Feel Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser LLC is recalling Durex Real Feel condoms because five batches failed burst pressure specifications.

    Product
    Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2019·2019-03-20

    Steris Recalls AMSCO 5000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 68 AMSCO 5000 Series Washer/Disinfector units because a software defect may prevent the intended cleaning cycle from processing, potentially leading to inadequate disinfection.

    Product
    AMSCO 5000 Series Washer/Disinfector Model # 5052
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1011-2019·2019-03-20

    US Endoscopy Padlock Clip Recalled for Potential Esophageal Laceration Risk

    US Endoscopy Group Inc is recalling Padlock Clip defect closure systems due to a risk of esophageal laceration during patient procedures.

    Product
    US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2019·2019-03-20

    Steris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 11 AMSCO 3000 Series Washer/Disinfector units because a software defect may prevent intended processing cycles, risking inadequate cleaning or damage to medical instruments.

    Product
    AMSCO 3000 Series Washer/Disinfector Model # 3052
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0991-2019·2019-03-20

    Linet AVE 2 Birthing Bed Recalled for Power Cable Safety Issue

    Linet Spol. S.r.o. is recalling 253 AVE 2 Birthing Beds because the power cable may break or fail, posing a risk of sparks or exposure to live conductors.

    Product
    AVE 2 Birthing Bed
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-0987-2019·2019-03-13

    Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect

    Getinge is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.

    Product
    Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
    Category
    Medical Device
    Distribution
    2 states