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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18951–18975 of 40124

  • SevereFDA (Devices)·Z-0370-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0360-2020·2019-11-20

    Canon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting

    Canon Medical System, USA, INC. is recalling nine Infinix DP-i catheterization tables because liquid spills can trigger a short circuit, causing the table to tilt without operator control.

    Product
    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2020·2019-11-20

    TriMed Locking Drill Guide Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 1,042 Locking Drill Guides because the epoxy coating on the instruments can pop off.

    Product
    TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2020·2019-11-20

    Carroll-Baccari Recalls Pedia Prep Skin Preparation Due to Contamination Risk

    Carroll-Baccari, Inc. is recalling Pedia Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 2,445 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0352-2020·2019-11-20

    Smiths Medical Recalls ProtectIV Plus Safety IV Catheters

    Smiths Medical is recalling certain lots of ProtectIV Plus Safety IV Catheters because the safety mechanism guard may be damaged.

    Product
    ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0368-2020·2019-11-20

    Carroll-Baccari Lemon Prep Skin Preparation Recalled for Potential Contamination

    Carroll-Baccari, Inc. is recalling Lemon Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 24,979 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0366-2020·2019-11-20

    TriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification

    TriMed Inc. is recalling 583 Olecranon Hook Plates because angled holes may have been modified from specifications without full qualification.

    Product
    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0404-2020·2019-11-20

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging

    Galil Medical is recalling 49 Visual-ICE Cryoablation Systems because the needles may clog or fail to freeze tissue adequately.

    Product
    Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0394-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0359-2020·2019-11-20

    TriMed Wrist Hook Impactors Recalled for Rust Risk

    TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.

    Product
    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2020·2019-11-20

    Draeger Infinity M300 Telemetry Devices Recalled for Cybersecurity Vulnerabilities

    Draeger Medical Systems is recalling Infinity M300 telemetry monitoring devices due to cybersecurity vulnerabilities including DDoS, Spoofing, and Tampering.

    Product
    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2020·2019-11-20

    Orthofix Recalls Elbow Sterile Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Elbow Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0348-2020·2019-11-20

    Basic Reset Energy FX Recalled for Adulteration and Misbranding

    Basic Reset Inc. is recalling Energy FX products because FDA determined the marketing claims rendered the product a medical device that was adulterated and misbranded.

    Product
    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0371-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0354-2020·2019-11-20

    Monarch Medical Technologies Recalls EndoTool SubQ Software Versions

    Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.

    Product
    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0396-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0350-2020·2019-11-20

    PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

    PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

    Product
    Universal Sexual Health Testing Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2020·2019-11-20

    Cadence Science Pressure Control Glass Syringes Recalled for Breakage Risk

    Cadence Science is recalling 237 Pressure Control Glass Syringes because they may break during use, posing a potential injury risk to patients and healthcare workers.

    Product
    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of non-sterile drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0387-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect

    Orthofix Srl is recalling UE Xcaliber Metadiaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2020·2019-11-20

    Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0380-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0406-2020·2019-11-20

    Siemens SOMATOM CT Scanner Software Recall for System Crashes

    Siemens Medical Solutions is recalling syngo CT VB20 software for SOMATOM CT scanners due to scan aborts and system crashes.

    Product
    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2020·2019-11-20

    TriMed Countersink Instruments Recalled Due to Epoxy Coating Defect

    TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.

    Product
    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide