The Recall Desk

Archive

July 2021 recalls

412 recalls were announced in July 2021.

What the numbers show

Critical
11
Severe
119
High
243
Moderate
36
Low
3

Of the 412 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

101–200 of 412

  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2021·2021-07-28

    Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk

    Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2021·2021-07-28

    NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure

    NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.

    Product
    NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2084-2021·2021-07-28

    Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport

    Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.

    Product
    Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2081-2021·2021-07-28

    Moderna COVID-19 Vaccine Administration Kits Recalled for Unsuitable Syringes

    McKesson is recalling 53,388 Moderna COVID-19 vaccine administration kits due to unsuitable 3mL syringes included in the kits. The affected kits were distributed May 4-24, 2021, and should not be used for vaccine administration.

    Product
    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21172·2021-07-28

    Birkenstock Kids' Mogami Sandals Recalled for Choking Hazard

    Birkenstock USA has recalled Kids' Mogami Sandals in sizes 24-28 because a plastic rivet can detach from the ankle strap, posing a choking hazard for young children. No injuries have been reported.

    Product
    Birkenstock Kids' Mogami Sandals Sizes 24-28
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0788-2021·2021-07-28

    Heidi's Brownies Recalled for Undeclared Soy Allergen

    Heidi's Brownies are being recalled because soy lecithin is listed in the ingredients but soy is not mentioned in the allergen declaration on the label, posing a risk to people with soy allergies.

    Product
    Heidi's Brownies is packaged in saran wrap in a plastic bag with a twist tie, 3 oz (85g). Label is read in parts: "***Heidi's ~~~ Brownies ~~~ *Malted barley wheat flour, cane sugar, water, chocolate chips (unsweetened chocolate, sugar, dextrose, soy lecithin (an…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0785-2021·2021-07-28

    Pow Pow Powders Hot Cocoa Mix Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders hot cocoa mix because the product lacks ingredient and allergen labeling, with undeclared milk present in the formulation.

    Product
    Pow Pow Powders: A standard of Quality Hot Cocoa Mix; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt), Cocoa (processed with alkali) Non-Fat Dry…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2103-2021·2021-07-28

    Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

    Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2021·2021-07-28

    Hip implant acetabular liners recalled for edge-loading and premature wear

    Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2021·2021-07-28

    Stimulen Collagen Moisturizing Lotion recalled for sterilization audit failure

    Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007) due to failure in the sterilization audit process. Approximately 2016 units were distributed to Malaysia.

    Product
    Stimulen Collagen Moisturizing Lotion, ST9555B
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-0689-2021·2021-07-28

    Erythromycin Topical Solution 2% Recalled for Failed Impurities Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.

    Product
    Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2021·2021-07-28

    Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport

    Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.

    Product
    026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2108-2021·2021-07-28

    Mindray battery cradle may prevent monitor from powering on

    Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

    Product
    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0690-2021·2021-07-28

    Erythromycin Topical Gel 2% Recalled Due to Failed Impurity Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Gel 2% due to failed impurities and degradation specifications. The recall affects approximately 22,824 tubes distributed nationwide.

    Product
    Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0665-2021·2021-07-28

    Acetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling

    LNK International is recalling Acetaminophen Extra Strength coated tablets because the primary label incorrectly states "enteric coated" when the tablets are not enteric coated and should be labeled as standard coated tablets.

    Product
    Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Food)·F-0789-2021·2021-07-28

    Kroger Vitamin D3 Softgels May Contain Undeclared Coq10

    Bountiful Trading Inc is recalling Kroger brand Vitamin D3 125 mcg softgels because they may contain undeclared Coq10. Consumers with allergies or sensitivities to Coq10 are at risk.

    Product
    Kroger brand, Vitamin D3 125 mcg softgels, 100 count, Green HDPE packaging
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·21V574000·2021-07-27

    Mack Recalls 2022 MD Trucks Due to Loose Front Suspension Bolts

    Mack Trucks is recalling 2022 MD trucks because loose front suspension bolts may detach, potentially causing loss of vehicle control and increasing crash risk.

    Product
    MACK — MACK MD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V573000·2021-07-27

    Mack Trucks Recalls 2021 LR, Granite, and TE Models for Brake Defect

    Mack Trucks is recalling 2021 LR, Granite, and TE vehicles because incorrect rear brake cams may cause inoperative rear axle brakes, increasing crash risk.

    Product
    MACK — MACK LR, GRANITE (GR), TE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21768·2021-07-27

    Oculus Quest 2 Removable Foam Facial Interfaces Due to Skin Irritation Risk

    Facebook Technologies is recalling about 4 million removable foam facial interfaces for Oculus Quest 2 virtual reality headsets because the foam can cause facial skin irritation and reactions. Consumers should stop using affected interfaces and contact the manufacturer for a free silicone replacement.

    Product
    Removable Foam Facial Interfaces for Oculus Quest 2 Virtual Reality Headsets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V571000·2021-07-27

    Newmar Recreational Vehicles Recalled for Window Adhesive Failure

    Newmar is recalling select 2018-2021 recreational vehicles due to potential window adhesive failure. The vent portion of affected windows may detach, increasing crash and injury risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR, LONDON AIRE, NEW AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V568000·2021-07-26

    Eclipse Recalls 2020-2021 Trailers Due to Gas Leak Risk

    Eclipse is recalling 2020-2021 Attitude, Stellar, and Iconic trailers because a stove bolt may be overtightened, damaging the seal and causing a gas leak.

    Product
    ECLIPSE — ECLIPSE ATTITUDE, ICONIC, STELLAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V566000·2021-07-26

    2021–2022 Spartan K2 RV Chassis Fuel Leak Recall

    Shyft Group is recalling certain 2021–2022 Spartan K2 RV Chassis vehicles with Cummins L9 Diesel Engines due to fuel leaks from pressurized hoses. The leak may increase fire risk if an ignition source is present.

    Product
    SPARTAN — SPARTAN K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V567000·2021-07-26

    Marion Body Works Recalls Spartan Fire Emergency Vehicles for Pump Defect

    Marion Body Works is recalling 2009-2021 Spartan Fire Gladiator and MetroStar emergency vehicles because a corroded solenoid may cause loss of water pressure.

    Product
    SPARTAN FIRE — SPARTAN FIRE METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V569000·2021-07-26

    2021 Audi E-Tron recalled for brake booster defect

    Volkswagen is recalling certain 2021 Audi E-Tron models due to improperly welded brake boosters that may separate, reducing braking assistance and stability control.

    Product
    AUDI — AUDI E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·025-2021·2021-07-24

    Top Notch Jerky Recalls Beef Jerky for Undeclared Anchovies

    Top Notch Jerky LLC is recalling 107 pounds of beef jerky because the product contains anchovies, a known allergen, that are not listed on the label.

    Product
    Top Notch Jerky LLC. Recalls Beef Jerky Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·21V565000·2021-07-23

    Autocar Recalls 2022 Xpeditor Trucks Due to Fuel Hose Leak Risk

    Autocar is recalling 2022 Xpeditor vehicles with specific diesel engines because a fuel hose may leak, increasing the risk of fire.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E067000·2021-07-23

    Terran Axle Trailer Axles Recalled for Improperly Tightened Spindle Nuts

    Terran Axle LLC is recalling Trailer Axles part number 020401 because improperly tightened spindle nuts may cause excessive vibration and overheating, increasing the risk of a crash.

    Product
    SUSPENSION:MULTIPLE AXLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V560000·2021-07-23

    GM Recalls 2017-2019 Chevrolet Bolt EVs for Battery Fire Risk

    General Motors is recalling 2017-2019 Chevrolet Bolt EVs because the high-voltage battery may catch fire when fully charged, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E068000·2021-07-23

    Ricon Baylift Wheelchair Lift Recall for Barrier Strength Defect

    Ricon is recalling Baylift Wheelchair Lifts because the outer barrier may fail to withstand maximum force, increasing injury risk.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY:WHEELCHAIR LIFT/RAMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21764·2021-07-22

    Bel Furniture Recalls Barrington 5-Drawer Chests for Tip-Over Hazards

    Bel Furniture is recalling about 90 Barrington 5-Drawer Chests because the dressers can tip over and trap children if not anchored to the wall. One child has already been injured when a chest tipped over.

    Product
    Barrington 5-Drawer Chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21766·2021-07-22

    Polaris RZR Off-Road Vehicles Recalled for Fire Hazard

    Polaris is recalling about 1,700 Model Year 2021 RZR Pro XP and RZR Pro XP 4 recreational off-road vehicles because a raised edge on the turbocharger casting can cause an oil leak and fire hazard.

    Product
    Model Year 2021 RZR Pro XP and RZR Pro XP 4 Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E066000·2021-07-22

    Continental Automotive Recalls Side Impact Air Bag Pressure Sensors

    Continental Automotive Systems is recalling PSAT side crash pressure sensors that may loosen due to improper mold cleaning, potentially delaying side air bag deployment.

    Product
    AIR BAGS:SENSOR:SIDE IMPACT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21767·2021-07-22

    Can-Am Defender HD10 Side-by-Side Vehicles Recalled for Fire Hazard

    BRP is recalling about 34,400 model years 2020 and 2021 Can-Am Defender HD10 side-by-side vehicles because the CVT air intake can become obstructed with snow, causing the drive belt to overheat and break and creating a fire hazard. BRP has received three reports of fires but no injuries.

    Product
    Model Years 2020 and 2021 Can-AM Defender HD10 side-by-side vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21765·2021-07-22

    Polaris GENERAL Recreational Off-Highway Vehicles Crash Hazard Recall

    Polaris is recalling Model Year 2021 GENERAL 1000, GENERAL 4 1000, GENERAL XP 1000, and GENERAL XP 4 1000 recreational off-highway vehicles because a weld between the brake pedal pivot bracket and EPS mounting bracket can separate, resulting in loss of brake function.

    Product
    Model Year 2021 GENERAL 1000, GENERAL 4 1000, GENERAL XP 1000 and GENERAL XP 4 1000 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0691-2021·2021-07-21

    Limar Hand Sanitizer recalled for deceptive container packaging

    Limar Hand Sanitizer (70% isopropyl alcohol) in 4 oz bottles is being recalled because the containers resemble drinking water bottles, creating a risk of accidental ingestion.

    Product
    Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0657-2021·2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for Microbial Contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes because certain lots were found to contain Burkholderia contaminans and/or yeast and mold through internal testing.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0656-2021·2021-07-21

    Durisan Antimicrobial Hand Sanitizer recalled for microbial contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions hand sanitizer due to internal testing that found contamination with Burkholderia contaminans and/or yeast and mold in certain lots.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V549000·2021-07-21

    Osage Recalls 2019 Ram Chassis Vehicles Due to Brake Line Chafing

    Osage is recalling 2019 Ram 4500 and 5500 chassis vehicles because improperly routed rear brake lines may chafe and leak fluid, increasing crash risk.

    Product
    OSAGE — OSAGE RAM 4500 CHASSIS, RAM 5500 CHASSIS, WARRIOR, SUPER WARRIOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21168·2021-07-21

    Harbor Freight Tank Top Propane Heaters Recalled for Burn Hazard

    Harbor Freight Tools is recalling about 350,000 One Stop Gardens tank top propane heaters because wind can redirect the flame to melt the safety shutoff, preventing the heater from turning off if tipped. Three minor burn injuries have been reported.

    Product
    One Stop Gardens 15,000 and 30,000 BTU Tank Top Propane Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2021·2021-07-21

    INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

    Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

    Product
    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1973-2021·2021-07-21

    Philips Respironics ventilators recalled due to foam degradation and chemical release

    Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.

    Product
    DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0774-2021·2021-07-21

    Cooked Snow Crab Sections Recalled for Salmonella and Listeria

    Cooked frozen snow crab sections from Crustaces Baie-Trinite Inc. are being recalled due to potential contamination with Salmonella and Listeria monocytogenes. The affected product was distributed to restaurant distributors in Massachusetts and Missouri.

    Product
    Cooked Snow Crab, Brine Frozen Sections, 2L and L sizes, Net Wt 13.15 kg / 29 lb
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2019-2021·2021-07-21

    INTUA CRT-P Pacemakers Recalled Due to Battery Degradation Risk

    The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.

    Product
    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1957-2021·2021-07-21

    Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing

    Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.

    Product
    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1974-2021·2021-07-21

    Philips Respironics ventilators recalled for degrading foam and chemical hazards

    Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.

    Product
    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0654-2021·2021-07-21

    Poseidon Platinum 3500 Capsules Recalled for Undeclared Prescription Drugs

    Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.

    Product
    Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·21V551000·2021-07-21

    Utilimaster Walk-In Van Recall for Loose Tie Rod Clamps

    Shyft Group is recalling 2021-2022 Utilimaster Walk-In vans because loose tie rod clamps could cause steering loss and increase crash risk.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V556000·2021-07-21

    Freightliner Chassis Recalled for Fuel Hose Leak Fire Risk

    Daimler Trucks North America is recalling 2021-2022 Freightliner XC and 2022 XB Chassis vehicles due to a fuel hose leak that increases fire risk.

    Product
    FCCC — FCCC XC CHASSIS, XB CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2021·2021-07-21

    VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets

    Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.

    Product
    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2020-2021·2021-07-21

    Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall

    Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.

    Product
    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0694-2021·2021-07-21

    Prairie Wolf Distillery Hand Sanitizer Recalled for Misleading Beverage-Like Packaging

    Prairie Wolf Distillery Alcohol Antiseptic 80% hand sanitizer is being recalled because the bottles resemble beverage containers, creating a risk of accidental ingestion. The recall affects all lots of both the 500 mL and 591 mL sizes distributed nationwide.

    Product
    Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1956-2021·2021-07-21

    Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk

    Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2015-2021·2021-07-21

    Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

    Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.

    Product
    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1958-2021·2021-07-21

    Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk

    Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.

    Product
    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V548000·2021-07-21

    Altec Recalls 2020 Aerial Work Platforms Due to Sprocket Weld Failure

    Altec is recalling 2020 AA and AN class vehicles because a failed weld on the leveling sprocket may cause uncontrolled platform movement, increasing the risk of injury and death.

    Product
    ALTEC — ALTEC AN-CLASS, AA-CLASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2021·2021-07-21

    Philips Respironics E30 ventilator foam degradation poses inhalation hazard

    Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.

    Product
    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2018-2021·2021-07-21

    Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

    Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.

    Product
    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2047-2021·2021-07-21

    Canon Vantage Galan 3T MRI System Recalled for Fire Risk

    Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.

    Product
    Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2021·2021-07-21

    Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure

    RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.

    Product
    Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2044-2021·2021-07-21

    Toshiba Vantage MRI System Recalled for Flame Retardancy Defect

    Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were distributed nationwide.

    Product
    Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2021·2021-07-21

    MRI System Patient Orientation Button May Cause Flipped Images

    GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.

    Product
    Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0772-2021·2021-07-21

    Trader Joe's Dark Chocolate Almond Butter Cups recalled for undeclared peanut allergen

    Bazzini LLC is recalling Trader Joe's Dark Chocolate Almond Butter Cups (1.4 oz, 2-cup packs) due to potential undeclared peanut allergen. Affected consumers should not consume the product if they have a peanut allergy.

    Product
    Trader Joes Dark Chocolate Almond Butter Cup, 1.4 oz. (2-20-gram cups per pack), PVC Pouch, 72 packs per case; 2 cups per pack .
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2077-2021·2021-07-21

    Urethral bulking system needles recalled due to sterility assurance failure

    Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.

    Product
    BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2021·2021-07-21

    MRI System User Interface Error May Cause Incorrectly Flipped Images

    GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.

    Product
    SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2050-2021·2021-07-21

    EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery

    Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.

    Product
    EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2021·2021-07-21

    Unifine Pentips Plus pen needles distributed with incorrect needle sizes

    Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.

    Product
    Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2021·2021-07-21

    GE SIGNA HDxt MRI System: Orientation Button Error Risk

    GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.

    Product
    1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2071-2021·2021-07-21

    Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance

    Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.

    Product
    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2021·2021-07-21

    GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue

    GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.

    Product
    SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2068-2021·2021-07-21

    Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance

    Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.

    Product
    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V554000·2021-07-21

    2021 BMW X2 Seat Belt Retractor Defect Increases Injury Risk

    BMW is recalling certain 2021 X2 vehicles because the passenger seat belt retractor may deactivate early, failing to comply with federal safety standards. The defective retractor could increase injury risk in a crash.

    Product
    MINI — MINI, BMW, TOYOTA COOPER SE, X1, 530I, 228I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2021·2021-07-21

    MRI Scanner Patient Orientation Button Confusion Affects Images

    GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.

    Product
    Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0780-2021·2021-07-21

    Living Free Nerve & Muscle Herbal Dietary Supplement Soy Allergen Undeclared

    Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Herbal Dietary Supplement because the label declares lecithin but does not specify that it contains soy lecithin, potentially endangering consumers with soy allergies.

    Product
    Living Free Nerve & Muscle Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Herbal Dietary Supplement***Herbal and Glandular…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2021·2021-07-21

    Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall

    Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.

    Product
    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2021·2021-07-21

    GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images

    GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.

    Product
    Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·21167·2021-07-21

    Caldwell E-Max Pro BT Earmuffs Recalled for Fire and Burn Hazards

    American Outdoor Brands is recalling Caldwell E-Max Pro BT Earmuffs with rechargeable lithium battery packs due to a soldering defect that can cause the unit to overheat, posing fire and burn hazards. No injuries have been reported.

    Product
    Caldwell E-Max® Pro BT Earmuffs with rechargeable lithium battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2021·2021-07-21

    Medical device software c4D fails to change site upon synchronization

    C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.

    Product
    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2021·2021-07-21

    Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure

    Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.

    Product
    Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V555000·2021-07-21

    2021 Nissan Rogue Sport Seat Belt Retractor Safety Defect Recall

    Nissan is recalling 2021 Rogue Sport vehicles because seat belt automatic locking retractors may deactivate prematurely, reducing protection for child safety seats and violating federal crash protection standards.

    Product
    NISSAN — NISSAN redundant ROGUE SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2021·2021-07-21

    Catheter Sheath Introducer Recalled for Size Labeling Discrepancy

    Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.

    Product
    Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0776-2021·2021-07-21

    Living Free Adult Extra Multi-Vitamin Recall for Undeclared Soy

    Bea Lydeckers Naturals Inc is recalling Living Free "Adult Extra" multi-vitamin capsules because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "**Living Free Adult Extra***Natural Vitamin Mineral Herbal Glandular Supplements***Formulated and…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0777-2021·2021-07-21

    Living Free Heart/Blood Vessel Dietary Supplement Recalls for Undeclared Soy

    Bea Lydeckers Naturals Inc is recalling Living Free Heart/Blood Vessel Dietary Supplement because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Living Free Heart/Blood Vessel Dietary Supplement, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Heart/Blood Vessel Dietary Supplement***Glandular Herbal & Vitamin…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2021·2021-07-21

    MRI Imaging System UI Defect May Cause Incorrect Image Orientation

    GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.

    Product
    SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2063-2021·2021-07-21

    MRI System Patient Orientation Button Click Error May Flip Images

    GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.

    Product
    Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2061-2021·2021-07-21

    SIGNA Artist MRI System Patient Orientation Button May Cause Flipped Images

    GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.

    Product
    SIGNA Artist, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0778-2021·2021-07-21

    Living Free Immune Dietary Supplement Soy Allergen Mislabeling Recall

    Bea Lydeckers Naturals Inc is recalling Living Free Immune Dietary Supplement because the label declares lecithin but does not declare that it contains soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Living Free Immune Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Immune Dietary Supplement***Glandular and Herbal Supplement***Formulated by Beatrice…
    Category
    Food
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2021.