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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Minimum severity

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

Clear filters

13776–13800 of 27471

  • HighFDA (Devices)·Z-1990-2020·2020-05-20

    Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy

    FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.

    Product
    Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2020·2020-05-20

    Cardiac Assist Recalls TandemLung Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - 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-1952-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - 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-1979-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 110 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2020·2020-05-20

    Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - 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-1967-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling 110,350 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 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2020·2020-05-20

    Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error

    Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.

    Product
    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2020·2020-05-20

    Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits

    Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.

    Product
    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1963-2020·2020-05-20

    DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

    DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

    Product
    DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e.…
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Devices)·Z-1847-2020·2020-05-13

    Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.

    Product
    Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2020·2020-05-13

    Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations

    Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.

    Product
    Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1791-2020·2020-05-13

    Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation

    Argon Medical Devices is recalling specific 0.035-inch guidewires because the stiffness of the soft end caused tissue perforation. The affected units were distributed to several countries outside the United States.

    Product
    0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1843-2020·2020-05-13

    Philips TEE Transducers Recalled Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.

    Product
    REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1863-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2020·2020-05-13

    Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation Risk

    Argon Medical Devices is recalling specific 0.035-inch guidewires because the soft tip stiffness caused tissue perforation. The affected units were distributed to several countries outside the US.

    Product
    0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1920-2020·2020-05-13

    ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error

    ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.

    Product
    REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1848-2020·2020-05-13

    Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation

    Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.

    Product
    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1911-2020·2020-05-13

    ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.

    Product
    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1912-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1913-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1865-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2020·2020-05-13

    Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest…
    Category
    Medical Device
    Distribution
    0 states