Archive
478 recalls were announced in June 2020.
Of the 478 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.
Which agencies issued them
Sonendo Inc is recalling 460 GentleWave foot pedals because the console may continue running for an extended period after the pedal is released.
Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
Cardinal Health is recalling Kangaroo Joey Safety Screw Spike sets because they may leak at the tube and spike connector interface.
The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.
Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.
Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.
Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.
Applied Medical Resources Corp is recalling 21 units of Dr. Thames Lap Chole laparoscopic graspers because a protruding rivet may cause tissue damage during use.
Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.
Cardinal Health is recalling Kangaroo Joey Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.
Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.
Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.
Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.
C.A. Greiner & Sohne Gesellschaftmbh is recalling VACUETTE Blood Transfer Units because needles may dislodge during use, posing a risk of needle stick injury or blood leakage.
Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.
Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.
Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.
Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.
Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.
Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.
Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.
Johnson Sea Products is recalling Home Style Crab Cakes because the packaging fails to list wheat and soybean oil as ingredients.
Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.
Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.
Wegmans is recalling Tuna Salad on Roasted Tomato Pita because the product may contain pieces of metal.
Wegmans is recalling 958 units of Tuna & Provolone Wheat Wraps because they may contain pieces of metal. Consumers should not eat the product.
Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.
MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.
Wegmans Food Markets is recalling 958 units of Tuna Salad due to the potential presence of metal pieces.
Absorb Health LLC is recalling 70 bottles of Advanced Joint Relief capsules because the ingredient panel failed to list a shellfish allergen.
Daimler Vans USA is recalling 2019-2020 Sprinter vans with swivel seats because incorrectly routed wiring may damage the front seat air bags.
Heartware, Inc. is recalling HVAD Pump Implant accessories due to potential tears in the outflow graft and breakage of the strain relief screw during assembly.
Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.
Heartware, Inc. is recalling 2,614 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.
Mondelez Global LLC is recalling Ritz Cheese Cracker Sandwiches, Family Size, due to undeclared peanut allergen. The product was distributed throughout the United States.
Cardinal Health is recalling Kangaroo 924 Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.
Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.
Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.
Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.
Medtronic is recalling 103 units of the Confida Expandable Sheath due to an increased risk of vascular complications, including bleeding, hematoma, and dissection.
Wegmans is recalling Tuna & Provolone Packaged Subs because they may contain pieces of metal. Consumers should not eat the product.
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.
Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.
Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.
Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.
Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.
Wuhan Bingbing Pharmaceutical is recalling LidoPro patches because manufacturing records and samples were lost, preventing verification of product stability.
Jindilli Beverages LLC is recalling 2,981 cases of Milkadamia Salted Buttery Spread due to the potential presence of mold.
Jindilli Beverages LLC is recalling Milkadamia Unsalted Buttery Spread due to the potential to contain mold. The product was distributed nationwide.
Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.
Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.
Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.
West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed a dissolution test at the end of their shelf life.
Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.
Medtronic is recalling the Guardian Connect App for iOS due to shortened transmitter battery life on specific iPhone, iPad, and iPod Touch devices.
CooperSurgical is recalling 1,740 units of Dilator/Sound Sets because the sterile pouch seal may be compromised, potentially affecting sterility.
CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.
GE Healthcare is recalling Giraffe Shuttle upgrade kits because the batteries emit a strong sulfur odor during charging.
Wuhan Bingbing Pharmaceutical is recalling LidoPatch pain relief patches because missing manufacturing records prevent verification that the product remains within specification through its expiration date.
PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The recall covers 14,030 bottles distributed nationwide.
Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.
Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Garza Food Ventures is recalling Siete Grain Free Cashew Flour Tortillas due to a potential to contain foreign material.
Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.
Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.
Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.
Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Bentley is recalling 1,892 2019-2020 Bentayga vehicles because a fuel line connector may leak, increasing the risk of fire.
Keystone RV Company is recalling 2020 Springdale trailers because they were equipped with incorrect axles and tires, which may cause the trailer to be overloaded and increase the risk of a crash.
Vee Tyre is recalling 522 Taiga A/T tires because the sidewall may separate, increasing the risk of a crash.
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