The Recall Desk

Archive

June 2021 recalls

771 recalls were announced in June 2021.

What the numbers show

Critical
10
Severe
106
High
384
Moderate
260
Low
11

Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

Which agencies issued them

301–400 of 771

  • HighFDA (Devices)·Z-1831-2021·2021-06-16

    Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions

    Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.

    Product
    Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2021·2021-06-16

    CooperSurgical Wallach Loop Electrode recalled for incorrect packaging

    CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.

    Product
    CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1811-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw locking mechanism failure

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate or unlock

    The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2021·2021-06-16

    Alphatec Insignia Cervical Plate System Screw Locking Mechanism May Disassociate or Unlock

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2021·2021-06-16

    Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2021·2021-06-16

    Ingenia Ambition X MRI Systems: Mechanical Defect in Hoisting Blocks

    Philips has recalled 156 Ingenia Ambition X MRI systems due to a mechanical defect in the hoisting blocks used to move the magnet during decommissioning or relocation. The defect poses a risk that the magnet could fall.

    Product
    Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1815-2021·2021-06-16

    Anterior Cervical Plate System Recalled for Potential Screw Mechanism Failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recalled for Potential Screw Failure

    Alphatec Spine recalled the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism, which could disassociate during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System screw mechanism failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate or unlock during or after spine surgery, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw failure recalled

    Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2021·2021-06-16

    Anterior Cervical Plate System Screw Lock Mechanism May Fail Intraoperatively or Postoperatively

    The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1845-2021·2021-06-16

    DePuy Synthes Hip Prosthesis Recall Due to Incorrect Size Labeling

    DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.

    Product
    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2021·2021-06-16

    Sodium Chloride 0.9% USP 1000 mL Recall for Temperature Abuse

    Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.

    Product
    Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2021·2021-06-16

    Medical microscope slide stainer recalled due to defective pump tubing

    Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.

    Product
    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2021·2021-06-16

    VIA Microcatheter VIA 21 Recalled for International Labeling Error

    MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.

    Product
    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0605-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2021·2021-06-16

    Levetiracetam Tablets 250 mg Recalled for Incorrect Barcode

    McKesson Corporation is recalling Levetiracetam Tablets USP 250 mg due to a barcode error that could cause some units to be misread as Naproxen 500 mg, although the product label itself is correct.

    Product
    Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2021·2021-06-16

    VIA Microcatheter shipped with incorrect international labeling instead of US labels

    MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.

    Product
    VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recall for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.

    Product
    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0662-2021·2021-06-16

    Glaceau Vitaminwater XXX mislabeled; may contain sugar instead of zero sugar

    The Coca-Cola Company is recalling Glaceau Vitaminwater XXX acai-blueberry-pomegranate labeled as zero sugar because an incorrect label was used and the product may actually contain sugar.

    Product
    Glaceau Vitaminwater XXX labeled to be Glaceau Vitaminwater Zero Sugar XXX acai-blueberry-pomegranate, 16.9 FL OZ, made for glaceau, Atlanta, GA
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0661-2021·2021-06-16

    Mideo's Marinara Glass Jars Recalled for Incorrect Potassium Labeling

    RC Industries Inc. is recalling Mideo's Marinara Glass 32oz jars because the potassium content listed on the label does not match the actual amount per serving.

    Product
    Mideo's Marinara Glass 32oz jars - 6 jars per case
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0657-2021·2021-06-16

    Garlic Alfredo Sauce Recall Due to Non-Food Grade Anti-Foamer

    Kerry Inc. is recalling Garlic Alfredo Sauce (product code 20607981) because the product was manufactured with a non-food grade anti-foamer ingredient. The affected sauce was distributed to AZ, CO, OK, TX, and WI.

    Product
    Garlic Alfredo Sauce. Product code 20607981. Keep Frozen. Net Wt. 30 lb. (13.61KG) Distributed By: Kerry Inc., Beloit, WI 53511.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0658-2021·2021-06-16

    Concentrated Creamy Alfredo Sauce recalled for non-food-grade anti-foamer

    Kerry Inc. is recalling Concentrated Creamy Alfredo Sauce (product code 20608306, lot 4771420) because it was made with a non-food-grade anti-foamer ingredient.

    Product
    Concentrated Creamy Alfredo Sauce. Product code 20608306. Keep Frozen. Net Wt. 40 lb. (18.14KG) Distributed By: Kerry Inc., Beloit, WI 53511.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0609-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2021·2021-06-16

    READYPREP CHG Chlorhexidine Gluconate Cloth recalled for superpotency

    Medline Industries is recalling READYPREP CHG 2% Chlorhexidine Gluconate Cloth because the product contains higher-than-specified levels of the active ingredient.

    Product
    READYPREP CHG — READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0606-2021·2021-06-16

    DELFELX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.

    Product
    DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0608-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1828-2021·2021-06-16

    VIA Microcatheter recalled due to incorrect international labeling shipped to US

    MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.

    Product
    VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·21V450000·2021-06-15

    2022 IC Bus school buses lack required emergency exit windows

    Navistar is recalling certain 2014–2022 IC Bus school buses that lack adequate emergency exit windows required by federal safety standards. The deficiency could delay passenger evacuation during emergencies.

    Product
    IC BUS — IC BUS CASB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E051000·2021-06-14

    Wallace Forge recalls medium duty adjustable mount couplers

    Wallace Forge is recalling specific medium duty adjustable mount couplers that may uncouple due to excessive play, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V447000·2021-06-14

    Kia K5 2021-2022 steering system defect increases crash risk

    Kia is recalling certain 2021-2022 K5 models with a power steering defect. The steering system may lose assist while driving due to a communication fault, increasing crash risk.

    Product
    KIA — KIA K5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·21V448000·2021-06-14

    Utilimaster Velocity Recalled for Incorrect Seating Capacity Placard

    Shyft Group is recalling 2021 Utilimaster Velocity vehicles because the tire and loading placard incorrectly states a seating capacity of one instead of two.

    Product
    UTILIMASTER — UTILIMASTER VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V446000·2021-06-13

    Rossmonster Ram Promaster Recall for Potential Gas Leak Fire Risk

    Rossmonster is recalling 2018 Ram Promaster vans because an overtightened saddle valve bolt may damage the o-ring seal, causing a gas leak that increases fire risk.

    Product
    ROSSMONSTER — ROSSMONSTER RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V445000·2021-06-11

    Host Campers Recalls 2019-2021 Trailers Due to Gas Leak Risk

    Host Industries is recalling 2019-2021 Cascade, Rainier, Tahoe, and Mammoth trailers because a stove bolt may damage the seal, causing a gas leak and fire risk.

    Product
    HOST CAMPERS — HOST CAMPERS RAINIER, TAHOE, CASCADE, MAMMOTH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V444000·2021-06-11

    2021 East to West Alta Travel Trailers: LP/CO Detector Placement Recall

    Forest River is recalling 2021 East to West Alta travel trailers because the LP/CO detector was installed in the incorrect location. This impairs propane leak and carbon monoxide detection, increasing fire and injury risks.

    Product
    EAST TO WEST — EAST TO WEST ALTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V443000·2021-06-11

    2021 Forest River Wildwood and Salem Trailer Clearance Lamp Defect

    Forest River is recalling 2021 Wildwood and Salem trailers because red and amber clearance lamps do not reflect enough light. This visibility defect increases the risk of crashes with other vehicles.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V440000·2021-06-10

    Emergency jack fracture risk affects Chevrolet Trailblazer and Buick Encore GX

    General Motors is recalling approximately 135,400 certain 2020-2022 Buick Encore GX and 2021-2022 Chevrolet Trailblazer vehicles because their emergency jacks can fracture if not positioned correctly, risking vehicle collapse.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAILBLAZER, ENCORE GX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21754·2021-06-10

    Children's Barhee Fishing Hero Toy Games Recalled for Excessive Lead Content

    Blue Star Trading is recalling about 300 Barhee Fishing Hero toy games sold on Amazon.com because metal rollers on the flying dinosaur figures contain lead levels exceeding the federal ban. Lead is toxic to young children if ingested.

    Product
    Children's Barhee Fishing Hero Toy Games
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V438000·2021-06-10

    2021 RAM 1500 rearview camera may fail to display, increasing crash risk

    Certain 2021 RAM 1500 vehicles may have a rearview camera that doesn't display due to a software issue in the trailer reverse steering module. This reduces rear visibility and increases the risk of crashes.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V421000·2021-06-10

    2021 Buick Envision air bag warning lamp may fail to illuminate

    GM is recalling 2021 Buick Envision vehicles—the air bag warning lamp may fail to illuminate due to a module defect. Owners should contact their dealer for a free software update.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SUBURBAN, ESCALADE ESV, TAHOE, ESCALADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21753·2021-06-10

    2021 Can-Am Outlander and Renegade ATVs Recalled for Crash Hazard

    BRP is recalling about 4,600 model year 2021 Can-Am Outlander and Renegade ATVs because the steering knuckle can detach from the lower arm, causing loss of control and crash risk.

    Product
    2021 Can-Am Outlander and Renegade ATVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V441000·2021-06-10

    Thor Motor Coach Motorhomes Recalled for Missing LP Tank Heat Shield

    Thor Motor Coach is recalling 2018-2022 Axis and 2018-2021 Vegas motorhomes with missing heat shields between the LP tank and chassis muffler. A missing heat shield increases fire risk; dealers will install the shield free of charge.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH VEGAS, AXIS, redundant AXIS, redundant VEGAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1651-2021·2021-06-09

    Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk

    FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0627-2021·2021-06-09

    Pfizer Lidocaine and Bupivacaine Injection Label Mix-Up Recall

    Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1620-2021·2021-06-09

    Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution

    The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.

    Product
    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0626-2021·2021-06-09

    Bupivacaine and Lidocaine Injection Vials Recalled for Label Mix-Up

    Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0633-2021·2021-06-09

    Mahayograj Guggulu Dietary Supplement Recalled for High Lead Contamination

    Garry N Sun USA Inc. is recalling Mahayograj Guggulu dietary supplement capsules and powder due to high lead levels detected in a consumer sample. The product was distributed across multiple U.S. states and Canada.

    Product
    Mahayograj Guggulu; 120 Vegetarian Capsules, 1/2 lb. bags of powder Dietary Supplement, 1030 Matley Lane, Unit A Reno, NV 89502 Serving size: 2 capsule Servings per container: 60 Proprietary Blend - 500 mg Certified Organic Distributed by Garry N Sun USA
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0645-2021·2021-06-09

    Peppa Pig Chocolate Chip Cookies Recalled for Undeclared Egg Allergen

    PRIMARY COLORS DESIGN CORP is recalling Peppa Pig brand chocolate chip cookies due to undeclared egg allergen on the packaging. The recall affects 294 boxes distributed in Georgia, lot number 091820.

    Product
    Peppa Pig brand chocolate chip cookies. One 7 oz bag per box- 6 boxes per case
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21V437000·2021-06-09

    Karavan Recalls 2021 Move I 1500 Long Trailers Due to Axle Weld Defect

    Karavan is recalling 2021 Move I 1500 Long trailers because improperly welded wheel spindles can break, causing the wheel to detach and increasing crash risk.

    Product
    KARAVAN — KARAVAN MOVE I 1500 LONG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1619-2021·2021-06-09

    Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution

    LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.

    Product
    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0646-2021·2021-06-09

    Giant Eagle Chicken Street Taco Kit recalled for undeclared egg allergen

    Giant Eagle is recalling Chicken Street Taco Kit packages due to undeclared egg allergen. The affected product was distributed to stores in PA, WV, OH, and IN.

    Product
    Giant Eagle Chicken Street Taco Kit; 20 oz (1 lbs 4 oz) Individual Units, PLU Code beginning 256598 00000
    Category
    Food
    Distribution
    4 states
  • SevereCPSC·21150·2021-06-09

    Klein Tools Non-Contact Voltage Tester Recalled for Shock Hazard

    Klein Tools non-contact voltage testers (model NCVT-1) are recalled because the on/off button can fail to disengage, causing the tester to malfunction and potentially fail to detect live voltage. One shock injury has been reported.

    Product
    Klein Tools Non-Contact Voltage Tester Model NCVT-1
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2021·2021-06-09

    Zavation InterV 10G kyphoplasty kits recalled due to inadequate sterilization

    Zavation is recalling InterV 10G Kyphoplasty Kits because products distributed as sterile may not have been adequately sterilized. The recall affects 503 units distributed nationwide.

    Product
    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2021·2021-06-09

    Zavation ZVplasty Direct Access Beveled Tip Surgical Trocars Recalled for Inadequate Sterilization

    Zavation is recalling 335 units of ZVplasty Direct Access Beveled Tip Trocars (10 Gauge) used in orthopedic and spinal procedures because affected units may not have been adequately sterilized.

    Product
    ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2021·2021-06-09

    Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized

    Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.

    Product
    10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2021·2021-06-09

    ZVplasty System spinal implant recalled due to inadequate sterilization

    Zavation is recalling ZVplasty System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.

    Product
    ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2021·2021-06-09

    ZVplasty orthopedic surgical devices may lack adequate sterilization

    Zavation is recalling 24 units of the ZVplasty System used in orthopedic and spinal procedures due to potential inadequate sterilization. Patients who received recalled devices should contact their healthcare provider.

    Product
    ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2021·2021-06-09

    Tranberg MR Stylet Recalled Due to Inadequate Sterilization

    CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.

    Product
    Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2021·2021-06-09

    Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

    Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site infection.

    Product
    10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2021·2021-06-09

    Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions

    Zimmer is recalling 16 units of its Natural Nail femoral implant due to potential commingling between two versions with different CCD angles (130 and 125 degrees). Wrong angle components could result in improper fracture fixation.

    Product
    Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1742-2021·2021-06-09

    Orthopedic bone access kits recalled for inadequate sterilization

    Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.

    Product
    10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2021·2021-06-09

    MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

    A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

    Product
    MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 0
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1755-2021·2021-06-09

    InterV 11G Kyphoplasty Kit Recall: Sterilization Defect May Increase Infection Risk

    Zavation is recalling 119 InterV 11G Kyphoplasty Kits distributed nationwide because they may not have been adequately sterilized, which could increase the risk of infection during spinal surgery.

    Product
    InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2021·2021-06-09

    Zavation ZVplasty Orthopedic System Recalled for Inadequate Sterilization

    Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.

    Product
    ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2021·2021-06-09

    Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization

    Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.

    Product
    10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2021·2021-06-09

    InterV Kyphoplasty Spinal Devices Recalled for Inadequate Sterilization

    Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 units distributed nationwide.

    Product
    InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2021·2021-06-09

    Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization

    Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.

    Product
    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2021·2021-06-09

    Oral Surgery Devices Recalled for Potential Sterility Failures

    Meta C.G.M. Spa is recalling MICROSS oral surgery devices due to sterility concerns. Units labeled as sterile may not have been adequately sterilized.

    Product
    REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1758-2021·2021-06-09

    Zavation ZVplasty Double Balloon Kit Recalled Due to Inadequate Sterilization

    Zavation recalls ZVplasty 10G, 10mm Double Balloon Kits used in spinal surgery due to potential inadequate sterilization. Seven units distributed nationwide may not have met sterility standards.

    Product
    ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2021·2021-06-09

    Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization

    Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.

    Product
    InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2021·2021-06-09

    11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization

    Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.

    Product
    11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2021·2021-06-09

    Terumo Sarns TCM II cardiac temperature controller cleaning protocol failure

    The Sarns TCM II temperature control system used in cardiac surgery has been recalled due to inability to validate its cleaning protocol. Users are instructed to discontinue use and dispose of all affected devices.

    Product
    The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorpor
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1702-2021·2021-06-09

    ZVplasty Drill units may not have been adequately sterilized

    Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.

    Product
    ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2021·2021-06-09

    ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.

    Product
    ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2021·2021-06-09

    K2M Cascadia lumbar implants recalled for mislabeled dimensions

    K2M, Inc. is recalling Cascadia AN Interbody Convex lumbar implants due to incorrect dimensions listed on product labels for specific lot numbers and device sizes.

    Product
    Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2021·2021-06-09

    Zavation Vertebrex Spinal Balloon Kit May Not Be Properly Sterilized

    Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet sterility standards.

    Product
    VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0653-2021·2021-06-09

    Kumpunny's Lemon Sage Parmesan Cream Sauce Recalled for Undeclared Milk

    Kumpunny's LLC is recalling Lemon, Sage Parmesan & Romano Cream Sauce because the label does not declare milk, which is present in the product as heavy cream and butter.

    Product
    Lemon, Sage Parmesan & Romano Cream Sauce. The product is in a 12.6 oz. Mason glass jar, lid and ring, and tamper evident shrink wrapped. UPC 8 60001 31924 8. The label is read in parts: "*** LEMON SAGE PARMESAN & ROMANO CREAM SAUCE *** Ingredients: Heavy whipping cream, white
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1691-2021·2021-06-09

    Draeger Evita V800 Ventilator Recalled for Multiple Software Defects

    Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2021·2021-06-09

    Zavation Orthopedic Cement Delivery System Recalled for Sterilization Failure

    Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2021·2021-06-09

    K2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions

    K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Lot NCMT-4437923) due to product labeling that references incorrect length or height dimensions. Seven units were distributed to the US and internationally.

    Product
    Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2021·2021-06-09

    Babylog VN800 Critical Care Ventilator Recalled for Software Malfunctions

    Draeger Medical is recalling critical care ventilators due to software defects causing unexpected unit restarts, incorrect oxygen level alarms, and suspension of weaning therapy. Twelve units were distributed nationwide.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2021·2021-06-09

    Orthopedic spinal surgical device recalled for inadequate sterilization

    Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.

    Product
    10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2021·2021-06-09

    ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.

    Product
    ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2021·2021-06-09

    ZVplasty Directional Cement Cannula Long may lack adequate sterilization

    Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.

    Product
    ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2021·2021-06-09

    Orthopedic Cement Delivery Kits Recalled Due to Sterilization Concerns

    Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.

    Product
    10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2021·2021-06-09

    ZVplasty Biopsy Device Lot 20061369 Recalled for Inadequate Sterilization

    Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they may not have been adequately sterilized.

    Product
    ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2021·2021-06-09

    Philips BRILLIANCE VOLUME CT System cooling unit may eject from gantry

    A cooling unit in the Philips BRILLIANCE VOLUME computed tomography system may unexpectedly eject from the gantry, posing a risk of injury. Two affected units are being recalled.

    Product
    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2021.