Archive
456 recalls were announced in May 2020.
Of the 456 recalls this month scored against our rubric, 1% are Critical, 21% are Severe.
Which agencies issued them
Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.
Access Scientific LLC is recalling 30 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Access Scientific LLC is recalling 6,066 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Cardiac Assist, Inc. is recalling 10 TandemHeart Pump Kits because an assembly error may prevent the device from priming.
Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.
FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.
Argon Medical Devices is recalling Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.
FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration standards, posing a risk of incorrect patient diagnosis.
Handicare AB is recalling 997 EVA Floor Lifts (Models 400, 450, 600) in the US and Mexico because abnormal use could cause the liftarm joint to break, posing an injury risk.
ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
Natural Dairy Products is recalling Fairway Market 1% Milk because a sample tested positive for antibiotic residue. The product was distributed in seven states.
Edwards Lifesciences is recalling 35 HemoSphere oximetry cables due to intermittent communication caused by inconsistent crimping of connectors.
Natural Dairy Products is recalling Natural by Nature 1% Milk due to a sample testing positive for antibiotic residue. The product was distributed to seven states.
ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.
C.R. Bard is recalling 8,392 SureStep Foley Tray Systems because a white paper-type residue may be attached to the catheter.
Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.
The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.
Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.
ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.
Genicon is recalling 1,550 units of the EZee Single Use Specimen Retrieval Bag to provide updated labeling instructions for multiple specimen retrieval.
ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.
Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.
Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.
Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.
Natural Dairy Products is recalling Common Market 1% Milk (1/2 Gallon) because a sample tested positive for antibiotic residue.
Medtronic is recalling 83 Vertex Select Multi Axial Screws because the product length is shorter than labeled. The recall covers units distributed in California and Michigan.
ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.
W. L. Gore & Associates is recalling 141 Gore DrySeal Flex Introducer Sheaths because 16Fr devices were mislabeled as 14Fr.
Becton Dickinson is recalling 655 PowerGlide ST Midline Catheter Maximal Barrier Kits because they were packaged without the required lidocaine.
Dole Fresh Vegetables Inc is recalling Classic Kit Light Caesar salad kits due to a critical control point deviation involving low levels of chlorine in the wash process.
Dole Fresh Vegetables Inc is recalling Hearts of Romaine because a critical control point deviation resulted in low levels of chlorine during the wash process.
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.
Glaxosmithkline is recalling 288 packages of ChapStick Total Hydration Moisture Tint Peachy Keen due to observed separation in the secondary packaging.
Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Pretty in Pink due to observed separation in the secondary packaging.
Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Very Berry due to observed separation in the secondary packaging.
Altec is recalling 2018-2020 aerial devices and digger derricks because bolts securing the pedestal to the turntable may fail, increasing the risk of injury or death.
DTNA is recalling certain 2019-2021 Western Star 4700 and 5700 trucks. An undersized wire in the ground harness may cause a melted connector, leading to engine stall and increasing crash risk.
Mitsubishi is recalling specific Lancer, Outlander, and Outlander Sport vehicles because front cross members may corrode and detach, increasing crash risk.
Mitsubishi is recalling 2019-2020 Outlander and 2019 Outlander PHEV vehicles because the right-side second-row seat belt may be assembled incorrectly, potentially failing to restrain occupants in a crash.
Vantage Mobility International is recalling 2016-2019 modified Dodge Grand Caravans because a deteriorating fuel pump gasket may cause fuel leaks, increasing fire risk.
Forest River is recalling 2019-2020 XLR Micro Boost trailers because ramp door fasteners may loosen, causing the door to detach and potentially leading to injury or a crash.
Yamaha is recalling 2015-2018 XC155 scooters because cylinder head nuts may loosen, causing coolant to foul the spark plug and potentially leading to engine stalling.
Garia is recalling about 1,000 battery-powered golf and courtesy vehicles because a fuse can overheat and melt while charging, posing a fire hazard.
Organic Pure Oil is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.
John Deere is recalling 60-inch broom attachment kits for compact utility tractors because they lack the required Operator's Manual, posing an injury hazard.
Flybar is recalling Swurfer Kiwi Baby and Toddler Swings because a plastic stopper can detach, posing a fall hazard to the occupant.
Aromatics International is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.
Sterno Home is recalling Hampton Bay, Patriot, and Paradise path light kits because a defective power supply poses an electric shock risk.
Heartland is recalling 2020 Trail Runner, Wilderness, Mallard, and Prowler trailers because a U-bolt on the spare tire carrier may break, causing the tire to detach.
W8 Distributing is recalling Jade Bloom Wintergreen and Birch Sweet Essential Oils because the packaging is not child-resistant, posing a poisoning risk to young children.
Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.
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.
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.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
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.
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.
LiquidSpring is recalling specific suspension systems for 2019-2020 RAM 4500 and 5500 vehicles because the rear brake line may wear, causing brake failure.
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.
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.
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.
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.
Porsche is recalling 2,253 Cayenne vehicles because a fuel line connector may leak, increasing the risk of fire.
Volkswagen Group of America is recalling 2020 Audi A6, A7, and Allroad vehicles because the passenger airbag may not deploy properly, increasing injury risk.
Royal International Trading Inc. is recalling Tainy Boctoka Dry Fruits Mix because the product contains undeclared sulfites.
Medifast is recalling Optavia Old Fashioned Maple & Brown Sugar Oatmeal pouches because they contain undeclared milk.
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.
Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.
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.
Inpeco S.A. is recalling 23 Abbott Accelerator a3600 Centrifuge Modules because a loading algorithm defect may cause unbalanced loads that could damage the equipment.
Hodedah is recalling HI4DR 4-drawer chests because they may tip over or entrap children if not anchored to the wall.
Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.
Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
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.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
CME America is recalling BodyGuard Microset infusion sets because the installed filter may have the incorrect pore size. The recall affects 30,300 units distributed nationwide.
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.
Stryker is recalling 26,298 units of Spy-Phi Drapes and Packs because sterile drapes were packaged in unsealed pouches, compromising sterility.
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.
ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.
ICU Medical is recalling 350 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.
Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.
Philips is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.
NuVasive Inc. is recalling MAGEC 2 spinal rods because actuator end caps may separate, exposing internal components and releasing titanium wear debris.
Volkswagen is recalling 2020 Audi Q8 vehicles because a defective transmission oil pipe may leak fluid, making roads slippery and increasing crash risk.
Looking for a different month? Back to 2020.