Archive
863 recalls were announced in August 2018.
Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.
Which agencies issued them
Olympus is recalling 2,399 Uretero-reno fiberscopes because the insertion tube bending section may break during surgery.
H&H Sports Protection is recalling VCAN V531 motorcycle helmets because the straps may not be properly sewn, potentially failing to stay secured during a crash.
J and J Bunting, Inc. is recalling Kowalski's Markets kalbi rub because it contains wheat, which is not declared on the label.
Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.
Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.
RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.
Life Technologies is recalling 70 units of Gibco DMEM cell culture medium because compromised fill port seals may allow media to leak and grow mold.
Siemens is recalling six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.
AMPI is recalling specific lots of whey powder because they may be contaminated with Salmonella. The product was distributed to nine states.
Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.
H-E-B is recalling Creamy Creations Vanilla Chocolate Ice Cream Cups due to a potential risk of containing metal fragments.
Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.
Ad-Tech Medical Instrument Corporation is recalling 65 Drill Sleeve Guides because raw material diameter was under tolerance, which could cause drill bits to seize during surgery.
Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.
Life Technologies is recalling 141 units of GIBCO CTS AIM V Serum-Free Media because compromised seal integrity may allow media to leak and grow mold.
Bard Medical Division is recalling 5,608 Arctic Sun 5000 Temperature Management Systems because an improper wiring connection may cause overheating and component failure.
Sun Pharmaceutical Industries is recalling Testosterone Cypionate Injection vials because organic and inorganic particulate matter was detected in the product.
Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.
Tactical Medical Solutions is recalling 1,097 units of BLAST Bandages, Lot 0617, because they were not terminally sterilized.
Forte Automation Systems is recalling 13 patient positioning systems in California due to periodic communication failures with the accuracy filter that may not be indicated to the operator.
Biscomerica, Inc. is recalling Sweet Serenity Caramel Sea Salt Chocolate Chip Cookies because the packaging fails to list milk in the 'contains' statement, despite milk being an ingredient.
Life Technologies is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium due to compromised fill port tube seals that may allow mold growth.
Olympus is recalling 1,062 Uretero-reno fiberscopes URF-P6 because the insertion tube bending section may break during surgery.
Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications.
Olympus is recalling 2,548 Uretero-reno videoscopes because the insertion tube bending section may break during surgery.
Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.
Kerry Inc is recalling 165,600 lbs of Soy Honey Cluster distributed in Minnesota because an ingredient was processed on equipment linked to a salmonella outbreak.
H-E-B is recalling Creamy Creations Orange and Lime Sherbet Cups due to a potential risk of containing metal fragments. The product was distributed in Texas.
Siemens is recalling 40 ARTIS Pheno Fluoroscopic X-Ray systems because the C-arm can drop up to 40 mm during specific high-speed rotations.
Implantcast GmbH is recalling specific 2M insert 15degree orthopedic hip implant components because the retaining ring may be incorrectly mounted.
Guangzhou Improve Medical Instruments Co., Ltd. is recalling 200,000 Prevent G Safety Winged Blood Collection Sets in Kansas due to leak complaints.
BMC is recalling about 430 Timemachine 01 bicycles because insufficient space between the front wheel and downtube poses a fall hazard. Four fall incidents were reported, including one broken finger.
DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.
GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.
Life Technologies is recalling Gibco DMEM tissue culture medium because compromised seal integrity may allow media to leak and grow mold.
May Flower International Inc. is recalling 3+2 Soda Crackers in New York because the product contains undeclared milk.
Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.
Papa John's Salads & Produce is recalling Superfood Salad Kits because peanuts were packed instead of cashews, creating an undeclared allergen hazard.
Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.
Ethicon, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.
OMNIlife science Inc. is recalling 16 units of ApeX-LNK Acetabular Inserts due to improper labeling on internal packaging and patient labels.
Abbott is recalling 2,521 CardioMEMS Patient and Hospital Electronics Units because they may display a false Error 5 message due to a configuration defect.
Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.
Prinova US LLC is recalling Amino Life brand L-Leucine Instant Sunflower because it contains cyclamates, an artificial sweetener prohibited in the United States.
Prinova US LLC is recalling Reginator NV (41825) because it contains cyclamates, an artificial sweetener prohibited in the United States.
Brewer Company is recalling seven Access Hi-Low Exam Tables because over-crimped wire harness connectors may affect the vertical side switches.
Prinova US LLC is recalling Amino Life brand BCAA 2:1:1 Instant Sunflower due to the detection of cyclamates, an artificial sweetener prohibited in the United States.
Sisel International LLC is recalling SiselRipt postWORKOUT dietary supplements because they contain Cyclamates, an unapproved artificial sweetener.
Human Design Medical is recalling 45 Vivo 65 home ventilators because some devices have an unreleased version of the Firmware upgrade tool.
GE Healthcare is recalling 58 Brivo XR385 digital radiographic systems because placing weight on the detector can cause image artifacts, leading to patient exam retakes.
Bio-Rad is recalling 153 PR4100 Microplate Readers because the power supply connector can fit incompatible components, risking irreparable damage to the system.
Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.
Prinova US LLC is recalling MRI Amintoten Strawberry Powder due to the detection of cyclamates, an artificial sweetener prohibited in the United States.
Terumo is recalling Tubing Pack Convenience Kits labeled with an incorrect expiration date of April 30, 2019.
Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.
CryoLife, Inc. is recalling BioGlue Spreader Tips because incorrect labels were applied to the packaging, and some required components were missing from the boxes.
Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.
Orca Bay Foods LLC is recalling 17 cases of decomposed wild-caught mahi-mahi loins sold in Florida, North Carolina, and Maryland.
Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.
Aidarex Pharmaceuticals is recalling 25 bottles of Enalapril Maleate 5mg due to out-of-specification degradation results during stability testing.
Nobel Biocare is recalling 74 units of Multi-Unit Abutments because the product labels are missing the lot number, expiration date, and other required information.
Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.
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