Archive
771 recalls were announced in June 2021.
Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.
Which agencies issued them
Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 units distributed nationwide.
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is used in orthopedic and spinal procedures.
Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip devices (Lot 11285ZV, 2001200) distributed nationwide for orthopedic spinal procedures because they may not have been adequately sterilized.
CamelBak is recalling certain caps sold with Podium and Peak Fitness water bottles because a small silicone valve can come loose and detach, posing a choking hazard. No injuries have been reported.
Zavation's VERTEBREX single balloon kit for spinal procedures is being recalled because distributed units may not have been adequately sterilized, creating a potential infection risk.
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Meta C.G.M. is recalling 150 units of SAFESCRAPER TWIST oral surgery instruments distributed in Texas and Florida due to sterility defects. Single-use sterile devices may not have been adequately sterilized, creating a risk of infection.
Zavation is recalling 10G beveled trocar/cannula instruments used in orthopedic and spinal procedures due to potential inadequate sterilization, creating infection risk.
Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Affected lot numbers 19113043 and 20041107 were distributed nationwide.
Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.
Zavation is recalling 19 units of ZVplasty 10G FLEX KYPHOPLASTY spinal devices because distributed units may not have been adequately sterilized, posing infection risk to patients.
Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
Clio LLC is recalling Clio Greek Yogurt Bar Honey 50g x 10-packs (UPC 861703000168) because they may contain metal fragments. Consumers should not consume the product and should contact the manufacturer or retailer.
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.
Zavation recalled ZVplasty Bipedicular Cement Delivery Cannulas (Lot 19123174) because products distributed as sterile may not have been adequately sterilized. These cannulas are used in spinal procedures; inadequate sterilization poses an infection risk.
Clio LLC is recalling Clio Yogurt Bar Coconut Less Sugar Bars due to possible metal fragments. The recall affects 93 units distributed nationwide.
Clio LLC is recalling Clio Yogurt Bar Berry Acai Less Sugar 10-packs due to the possible presence of metal fragments. The affected product was distributed nationwide.
Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.
Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.
Clio LLC is recalling Clio Greek Yogurt Bar Strawberry Minis due to the possible presence of metal fragments in the product. The affected pouches were distributed nationwide.
Zavation is recalling 11 units of ZVplasty Directional Cement Cannula from lot 20061366 because products distributed as sterile may not have been adequately sterilized. The affected devices were distributed nationwide.
Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.
Zavation is recalling 7 units of 11G DIRECT SINGLE spinal implants (lots 2001185 and 2001243) because products distributed as sterile may not have been adequately sterilized. The devices were distributed nationwide.
Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.
Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits due to inadequate sterilization. Products distributed as sterile nationwide may pose infection risk if used in spinal procedures.
Oxford Pharmaceuticals is recalling 6,864 bottles of Buspirone Hydrochloride Tablets, 15 mg, distributed nationwide due to the presence of foreign tablets or capsules in the product.
Clio LLC is recalling Clio No Added Sugar Yogurt Bars (Mixed Berry/Peach, 50g) due to possible metal fragments in the product. Approximately 1,880 units were distributed nationwide.
Clio LLC is recalling Clio Yogurt Bar Raspberry/Peach Mini Club pack (24g x 24) due to possible metal fragments in the product.
Clio LLC is recalling Clio Yogurt Bar Mixed Berry Low Sugar Bar 50g x 10 retail 10-packs nationwide due to possible metal fragments in the product.
Reser's Fine Foods is recalling Chicken Street Taco Kits because the Chipotle Crema component contains egg that is not declared on the label, posing a risk to consumers with egg allergies.
Clio LLC is recalling Clio Yogurt Bar Strawberry 10-packs distributed nationwide due to the possible presence of metal fragments in the product.
Clio LLC is recalling Clio Greek Yogurt Bar Vanilla 10-packs (UPC 861703000106) distributed nationwide due to the possible presence of metal fragments in the product.
Clio LLC is recalling Clio Greek Yogurt Bar Vanilla/Strawberry Club pack 50g x 12, 16pc tray due to possible metal fragments in the product. Consumers should not consume the affected product.
A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.
Zavation is recalling ZVplasty Unipedicular Cement Delivery Cannula Kits distributed nationwide due to potential inadequate sterilization of sterile surgical devices.
Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.
Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.
Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.
Zavation's 11G Diamond Trocar/Cannula, used in orthopedic and spinal procedures, may not have been adequately sterilized. The manufacturer is recalling affected units distributed nationwide.
CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Cannula due to potentially inadequate sterilization of certain lots. Affected units were distributed to medical facilities in the US and internationally.
Meta C.G.M. Spa recalls 27 units of REF 4890 SMARTSCRAPER oral surgery instruments distributed in Texas and Florida. The sterile-labeled devices may not have been adequately sterilized.
Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.
Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.
Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were distributed nationwide.
Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.
Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit due to products potentially lacking adequate sterilization. The 15 units affected (Lot 20071774, 19123262) were distributed nationwide.
Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.
Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 units distributed nationwide.
Zavation's 10G Direct Single Bone Access Kits are being recalled because products distributed as sterile may not have been adequately sterilized, posing infection risk in orthopedic procedures.
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
Zavation recalled 14 units of ZVplasty Bipedicular Cement Delivery Cannula Kits distributed nationwide because they may not have been adequately sterilized.
Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.
Zavation is recalling 56 units of 10 Gauge Direct Unilateral Stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Patients who received this device should contact their healthcare provider.
Zavation is recalling 79 units of the ZVplasty 10G, 15mm Single Balloon Kit due to inadequate sterilization. Affected devices may pose a contamination risk for patients undergoing spinal procedures.
Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.
Siemens is recalling Multitom RAX imaging systems (software version VF10) due to rare software issues affecting beam alignment and radiation dose calculations.
Zavation's ZVplasty spinal surgical kit is being recalled because distributed units may not have been adequately sterilized. The recall affects 302 units distributed nationwide.
Fujifilm's Synapse Cardiovascular software versions 6.0.4 to 6.2.1 contain a defect in the Advanced Reporting function where previously assigned patient database identification numbers can be reused for new patients when specific patient merge operations are executed.
Zavation has recalled 10 gauge direct unilateral sterile stylets used in orthopedic and spinal procedures due to inadequate sterilization. Products distributed as sterile may not meet sterilization standards.
A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.
Signature Orthopedics is recalling Logical cup liners (hip implants) due to mislabeling with incorrect products in the package. Affected devices may not be suitable for implantation.
Zavation is recalling OsteoFlex Cement and Mixing System used in spinal and orthopedic surgery due to potential sterilization failures. The 846 units distributed nationwide may not be adequately sterilized, creating a contamination risk.
Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.
Getinge is recalling approximately 13,042 units of Nimbus 4 and Nimbus Professional alternating-pressure mattress overlays due to potential abnormal inflation that could impair pressure relief function.
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.
Zavation's 10G Coaxial Cannula with Tuohy Connection (Lot 20102495) used in spinal and orthopedic procedures has been recalled due to inadequate sterilization. Patients should contact their healthcare provider if they received this product.
Zavation is recalling 56 units of 10 gauge direct unilateral stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Affected units were distributed nationwide.
Zavation's ZVplasty Biopsy Device (11 Gauge, lot 20061370) is being recalled because distributed units may not have been adequately sterilized. The 34 affected units were distributed nationwide.
Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.
Terumo is recalling Sarns Temperature Control Monitor units (1,176 devices) because it cannot validate a cleaning protocol meeting current FDA requirements. Users should discontinue use and dispose of affected devices immediately.
Genpak is recalling Bake n Show Angel Food Trays (8-inch and 8-inch shallow models) because foreign objects were found in the product packaging. Consumers should stop using affected trays.
Genpak is recalling Bake n Show Round and Square Cake Trays due to the presence of foreign objects found in product packaging. The trays were distributed across multiple U.S. states and Canada.
Boehringer Ingelheim Pharmaceuticals is recalling Micardis 80 mg tablets (Lot #860412, expiration September 2022) because the tablets contain less active ingredient than required. This is a voluntary Class II recall.
Genpak is recalling Bake n Show Pizza Cookie Trays (12") because foreign objects were found in product packaging. The recall affects multiple states and Canada.
MARVAO MEDICAL DEVICES is correcting the Directions for Use (DFU) for NexSite HD hemodialysis catheters to ensure consistency between field documentation and website information for 292 devices distributed in the U.S.
Genpak is recalling Bake n Show Muffin Trays in three sizes due to the discovery of foreign objects in product packaging. The recall affects units distributed across multiple US states and Canada.
Wegmans Food You Feel Good About Everything Bagel Seasoned Hummus may contain pieces of hard black plastic. The product was distributed in Massachusetts, New York, Pennsylvania, New Jersey, Maryland, Virginia, and North Carolina.
Hi Tech Pharmaceuticals is recalling Lipodrene With 25mg Ephedra Extract because the product contains 1,4-dimethylamylamine (DMAA), an unapproved food additive.
Genpak is recalling Bake n Show Oven Ready Food Trays (16 ounce) due to foreign objects found in the packaging. The affected product was distributed across multiple U.S. states and Canada.
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants with mislabeled product dimensions. The affected sizes include 10x22x14mm, 10x28x14mm, and 10x22x15mm. No injuries have been reported.
Wegmans Food Markets is recalling its 7-pound bagged ice products due to possible contamination with metal fragments. The recall affects products distributed in New York, Massachusetts, and Pennsylvania.
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.
Jaguar Land Rover is recalling 2020-2022 Defender X vehicles with smoked rear lights because a voltage spike can cause turn signals and brake lights to fail.
Honda is recalling 2022 Odyssey vehicles because second-row outboard seat frames have deformed locking mechanisms that may prevent them from locking into place. Unlocked seats could move unexpectedly, increasing injury risk.
One More Auto Parts is recalling Lasfit headlight bulbs that are too bright during the first ten minutes of use, posing a crash risk.
Coach House is recalling 2021 Platinum vehicles because an overtightened bolt on the cooking stove may damage the seal, causing a gas leak that increases fire risk.
Highland Ridge RV is recalling certain 2019-2021 fifth wheel and travel trailers because a propane regulator may fail, increasing fire risk.
KZRV is recalling 2018-2019 Sidewinder RVs because a propane regulator may fail, increasing pressure and fire risk.
Keystone is recalling 2019 Bullet and Sprinter and 2020 Hideout RVs because a propane regulator may fail, increasing fire risk.
Trails West is recalling one 2020 Sierra 4H 15x19 LQ trailer due to a potential gas leak from the stove that could increase fire risk.
Jayco is recalling approximately 87,649 certain 2017-2021 travel trailers and fifth wheels with defective Winntec propane regulators that may fail and increase fire risk.
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