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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13701–13725 of 27500

  • HighFDA (Devices)·Z-2084-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2020·2020-05-27

    BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

    Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

    Product
    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2020·2020-05-27

    NelDerm Hydrogel Dressing Recalled for Foreign Material in Packaging

    Nelson Innovations is recalling NelDerm Hydrogel Dressings due to foreign material near the adhesive edge within the pouch packaging.

    Product
    NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2040-2020·2020-05-27

    Medline Recalls Surgical Kits Due to Potential Loss of Sterility

    Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.

    Product
    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2020·2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2020·2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2020·2020-05-27

    Medline Recalls Silicone Foley Catheters Due to Loose Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2020·2020-05-20

    Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure

    Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.

    Product
    Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults

    Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.

    Product
    da Vinci Xi Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1945-2020·2020-05-20

    Beckman Coulter iQ200 Urine Analyzer Recalled for Electrical Short Risk

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.

    Product
    iQ200 Series Urine Microscopy Analyzer- All part numbers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2020·2020-05-20

    Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.

    Product
    iChem¿VELOCITY Urine Chemistry System-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1933-2020·2020-05-20

    Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure

    Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.

    Product
    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1991-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2020·2020-05-20

    Inpeco Abbott Accelerator a3600 Interface Module Recalled for Cross-Contamination Risk

    Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2020·2020-05-20

    Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing

    Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.

    Product
    EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2020·2020-05-20

    Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error

    Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2020·2020-05-20

    Argon Medical Devices Recalls PAC Tray Catheter Introducer Kits

    Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components that may increase the risk of needle sticks.

    Product
    PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1969-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.…
    Category
    Medical Device
    Distribution
    Distributed nationwide