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

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Minimum severity

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

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34701–34725 of 40449

  • HighFDA (Devices)·Z-0054-2015·2014-10-15

    ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2015·2014-10-15

    ArjoHuntleigh Contoura C1000 and C1080 Bariatric Beds Recalled for Entrapment Risk

    Arjo Hospital Equipment AB is recalling 1,695 Contoura C1000 and C1080 bariatric beds worldwide due to a low but existing risk of patient entrapment for individuals with a BMI under 40.

    Product
    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2015·2014-10-15

    DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage

    DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.

    Product
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2015·2014-10-15

    Richard Wolf Recalls Hulka Clip Tubal Occluding Device Lot 51000232

    Richard Wolf Medical Instruments is recalling Hulka Clip Tubal Occluding Devices (Lot 51000232) due to a biocompatibility test discrepancy found in a subsequent lot.

    Product
    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2015·2014-10-15

    Biomet Compress Face Reamer Recalled for Missing Helix Angle

    Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.

    Product
    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0026-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

    Product
    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling BioFlo PICC kits because included BD syringes had open seals, potentially affecting sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0062-2015·2014-10-15

    Orthohelix MaxLock Reamer Recalled for Incorrect Laser-Etched Sizing

    Orthohelix Surgical Designs is recalling 38 MaxLock Extreme Mod-Foot Concave Reamers because incorrect sizing was laser-etched on the devices.

    Product
    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0033-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2015·2014-10-15

    Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.

    Product
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

    Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Issues

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2714-2014·2014-10-08

    Teleflex Recalls Hudson Pediatric Anesthesia Breathing Circuits Due to Cracking

    Teleflex Medical is recalling Hudson RCI Pediatric Anesthesia Breathing Circuits because they can crack prior to and during use.

    Product
    Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2015·2014-10-08

    Siemens Ysio Max Radiographic Systems Recalled for Image Loss Risk

    Siemens is recalling Ysio Max radiographic systems because a malfunction can cause images to be lost, requiring patients to repeat examinations.

    Product
    Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2015·2014-10-08

    Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk

    Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.

    Product
    Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2015·2014-10-08

    Siemens Uroskop Omnia Max X-Ray System Recalled for Image Loss

    Siemens is recalling two Uroskop Omnia Max systems because a malfunction causes image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2015·2014-10-08

    Siemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors

    Siemens is recalling five Luminos Agile Max systems due to malfunctions that cause image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2014·2014-10-08

    Zimmer Recalls Persona Knee System Female Screws Due to Stripping Risk

    Zimmer, Inc. is recalling 16,380 units of Persona The Personalized Knee System 2.5 mm Female Screws due to potential stripping of the hex driver when used in cortical bone.

    Product
    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide