The Recall Desk

Archive

April 2022 recalls

391 recalls were announced in April 2022.

What the numbers show

Critical
7
Severe
66
High
258
Moderate
58
Low
2

Of the 391 recalls this month scored against our rubric, 2% are Critical, 17% are Severe.

1–100 of 391

  • SevereUSDA FSIS·012-2022·2022-04-29

    Wayne Farms Recalls Undercooked Ready-to-Eat Chicken Breast Fillets

    Wayne Farms is recalling approximately 30,285 pounds of ready-to-eat chicken breast fillets that may be undercooked. The recall was initiated after a customer complaint.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Ready-to-Eat Chicken Breast Fillet Products That May Be Undercooked
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V287000·2022-04-28

    Micro Bird Recalls Transit and School Buses for Electrical Fire Risk

    Micro Bird is recalling 2006-2021 transit and school buses because a damaged electrical harness may short circuit and cause a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, G5 SCHOOL BUS, MB II SCHOOL BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V284000·2022-04-28

    2021 Jeep Grand Cherokee Recalled for Sticking EGR Valve

    Chrysler is recalling 2021 Jeep Grand Cherokee and Dodge Durango vehicles due to EGR valve defects that may cause loss of drive power and increase crash risk. Dealers will provide free replacement.

    Product
    JEEP — JEEP, DODGE GRAND CHEROKEE 4XE, DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22745·2022-04-28

    Best Naturals Organic Wintergreen Essential Oil Non-Child-Resistant Packaging

    Best Naturals is recalling Organic Wintergreen Essential Oil sold online because the packaging does not meet federal child-resistant requirements. The product contains methyl salicylate and poses a poisoning risk if swallowed by young children.

    Product
    Best Naturals Organic Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V286000·2022-04-28

    Micro Bird Recalls School Buses Due to Electrical Harness Fire Risk

    Micro Bird is recalling 156 school buses from 2006-2021 because a damaged electrical harness may short circuit and cause a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04282022-01·2022-04-28

    USDA Issues Public Health Alert for Frozen Chicken Products Imported Without Reinspection

    USDA FSIS issued a public health alert for specific Trader Joe's frozen chicken products that were imported without the benefit of reinspection. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert for Ready-to-Eat Frozen Chicken Products Imported Without the Benefit of Import Reinspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·22127·2022-04-28

    Electric Start Pressure Washers Recalled for Carbon Monoxide Hazard

    Generac Power Systems is recalling about 53,000 Generac and DR Power electric start pressure washers because the electronic start/stop button can malfunction and cause the unit to self-start, posing a carbon monoxide poisoning risk in confined spaces.

    Product
    Electric Start Pressure Washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22746·2022-04-28

    Yamaha Off-Road Motorcycles Recalled for Crash Hazard

    Yamaha is recalling about 760 off-road motorcycles because the gear shift assembly can detach from the crankcase, causing unintentional gear shifting and posing a crash hazard. No injuries have been reported.

    Product
    Off-road motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V285000·2022-04-28

    2022 Toyota Tundra Rearview Camera Display Failure in Cold Weather

    Certain 2022 Toyota Tundra vehicles may fail to display the rearview camera during cold weather, violating Federal Motor Vehicle Safety Standard #111 and increasing crash risk. Toyota will reprogram the software free of charge.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E035000·2022-04-28

    Suburban SDS2 Cooktop Recall Due to Gas Leak Risk

    Suburban Manufacturing is recalling SDS2 2-Burner Drop-in Cooktops because internal tubes may fracture and cause a gas leak.

    Product
    EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22126·2022-04-28

    Bed Bath & Beyond Recalls Woven Bunny Baskets Due to Choking Hazard

    Bed Bath & Beyond is recalling H for Happy™ Woven Bunny Baskets because the plastic eyes can detach, posing a choking hazard to young children. About 12,800 units were sold at Bed Bath & Beyond stores and online in March 2022.

    Product
    H for Happy™ Woven Bunny Baskets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22743·2022-04-28

    Amazon Recalls AmazonBasics School Classroom Stack Chairs

    Amazon is recalling about 22,400 AmazonBasics School Classroom Stack Chairs because the frame welds can fail, creating a fall hazard. No injuries have been reported.

    Product
    AmazonBasics School Classroom Stack Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22744·2022-04-28

    Polaris 2022 RZR Pro R 4 Recreational Vehicles Fire Hazard

    Polaris is recalling approximately 1,160 Model Year 2022 RZR Pro R 4 Premium and Ultimate recreational off-road vehicles due to a fire hazard from an incorrectly routed battery cable that can contact the prop shaft.

    Product
    Model Year 2022 RZR Pro R 4 Premium and RZR Pro R 4 Ultimate Recreational Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1003-2022·2022-04-27

    Carol's Cuts Fruit Tray Recalled for Salmonella Contamination

    Liberty Fruit Co Inc is recalling Carol's Cuts Fruit Tray because of Salmonella in the fresh-cut cantaloupe. The product was distributed to retail stores, military groceries, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Fruit Tray Ingredients may include Honeydew, cantaloupe, pineapple & red grapes. Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 5lb UPC: 852193101084 Best If Used By: 03/21/22, 03/23/22, 03/27/22 Product of: HND, GT, CR, PER.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1001-2022·2022-04-27

    Carol's Cuts Cantaloupe Chunks recalled for Salmonella contamination

    Carol's Cuts Cantaloupe Chunks are recalled due to Salmonella contamination. Products were distributed to retail, military, food service and school locations in Kansas, Missouri, Iowa and Nebraska.

    Product
    Carol's Cuts Cantaloupe Chunks Ingredients may include cantaloupe Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 8oz, Net Weight 16oz, or Net Weight 32 oz UPC: 85219301001, 852193900151, 852193932152 Best If Used By: 03/23/22, 03/27/22, 03/21/22, 03/23/22, 03/
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1006-2022·2022-04-27

    WFM 365 Organic Creamy Caesar Dressing Recalled for Undeclared Wheat and Soy

    Whole Foods Market is recalling WFM 365 Organic Creamy Caesar dressing due to undeclared wheat and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    WFM 365 Organic Creamy Caesar, 12oz, UPC#99482490290, Keep Refrigerated. Bottled in USA. Distributed by: Whole Foods Market Austin, TX
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0785-2022·2022-04-27

    FDA Recalls Pink Pussycat Sensual Enhancement Capsules for Undeclared Sildenafil

    Pink Pussycat Sensual Enhancement capsules are being recalled nationwide. The FDA found they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2022·2022-04-27

    artnaturals Hand Sanitizer Recalled for Benzene and Chemical Contamination

    artnaturals ethyl alcohol hand sanitizer (8 fl oz bottles, lot G20127E and G20128A, exp. 5/1/2022) is recalled nationwide due to chemical contamination including benzene, acetaldehyde, and acetal.

    Product
    artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2022·2022-04-27

    Carol's Cuts Fresh-Cut Cantaloupe Fruit Medley Recalled for Salmonella

    Carol's Cuts Fruit Medley is recalled due to fresh-cut cantaloupe testing positive for Salmonella. The affected product was distributed to retail, military, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Fruit Medley Ingredients may include Honey, cantaloupe, pine, and grape Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 8oz, Net Weight 16oz UPC: 852193001087, 852193900458 Best If Used By: 03/21/22, 03/23/22, 03/27/22, 03/26/22, 03/24/22 Product of
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1002-2022·2022-04-27

    Fresh-cut Hawaiian blend fruit recalled due to Salmonella

    Carol's Cuts Hawaiian Blend is being recalled due to Salmonella in fresh-cut cantaloupe. The product was distributed to retail stores, military facilities, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Hawaiian Blend Ingredients may include Honeydew, cantaloupe, pineapple, strawberries and blueberries Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 32 oz UPC: 852193321086 Best If Used By: 03/21/22, 03/23/22, 03/24/22, 03/26/22 Product of: USA. CRI
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1008-2022·2022-04-27

    Super Twa Mushroom Mixed Mushrooms Recalled Due to Listeria Monocytogenes

    Farm Fresh Produce LLC is recalling Super Twa Mushroom Mixed Mushrooms (14.11 oz) due to Listeria monocytogenes contamination identified in California. The recall affects 160 cases distributed in California only.

    Product
    Super Twa Mushroom Mixed Mushrooms; New Wt/When Packed) 14.11 oz. (400g) Keep refrigerated. UPC: 6957937481850
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1009-2022·2022-04-27

    Enoki Mushrooms Recalled Due to Listeria Monocytogenes Contamination

    Wisetrade Corporation is recalling Global Fresh Marketing Enoki Mushrooms because the California Department of Public Health detected Listeria monocytogenes contamination during product sampling. Consumers should not consume the product.

    Product
    Global Fresh Marketing Enoki Mushrooms Champignons d'Enoki Net Wt/Poids 200g/7.05 oz. Vacuumed Plastic bag UPC: 809728-95012 Wisetrade Corporation, Irvine, CA 92618
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0976-2022·2022-04-27

    Artis Q biplane X-ray systems cooling failure may prevent adequate tube cooling

    Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic system shutdown.

    Product
    Artis Q biplane, Model Number 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2022·2022-04-27

    Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

    Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.

    Product
    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2022·2022-04-27

    Qiagen therascreen KRAS RGQ PCR Kit Recall: False Positive/Negative Results

    Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.

    Product
    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0986-2022·2022-04-27

    Diagnostic imaging system software malfunction may interrupt clinical procedures

    Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.

    Product
    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2022·2022-04-27

    Acumed Cannulated Screws May Lack Sufficient Strength for Bone Fixation

    Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.

    Product
    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04272022-01·2022-04-27

    USDA Issues Public Health Alert for Ground Beef Due to E. coli O26

    USDA FSIS issued a public health alert for specific ground beef products produced in December 2021 due to possible E. coli O26 contamination. Consumers are advised to discard or return the affected items.

    Product
    FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. coli O26 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2022·2022-04-27

    Gallant DR Implantable Cardioverter Defibrillator Bluetooth Malfunction Affects Remote Monitoring

    St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.

    Product
    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2022·2022-04-27

    GE Healthcare MRI Systems May Fall During De-Installation Without Proper Rigging

    GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.

    Product
    GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2022·2022-04-27

    X-ray Imaging System Coolant Deficiency May Disable Equipment Operation

    The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.

    Product
    Artis Q ceiling, Model Number 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2022·2022-04-27

    X-ray Imaging System May Fail to Cool Tube Properly

    Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.

    Product
    Artis zee biplane MN, Model Number 10094143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0774-2022·2022-04-27

    Injectable Rifampin Recalled Due to Failed Quality Specifications

    Mylan Pharmaceuticals is recalling injectable Rifampin vials nationwide due to failed impurities and degradation specifications discovered during stability testing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2022·2022-04-27

    Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices

    Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2022·2022-04-27

    Siemens Artis zee biplane X-ray system cooling defect recall

    Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.

    Product
    Artis zee biplane, Model Number 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2022·2022-04-27

    Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk

    Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.

    Product
    Artis Q.zen ceiling, Model Number 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2022·2022-04-27

    Siemens Artis pheno diagnostic imaging system software malfunction recall

    Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.

    Product
    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2022·2022-04-27

    Artis zeego X-ray imaging system recalled for insufficient cooling

    Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.

    Product
    Artis zeego, Model Number 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2022·2022-04-27

    Acon Biotech Flowflex COVID-19 Rapid Test Recalled for Inaccurate Results

    Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.

    Product
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·22V283000·2022-04-27

    School buses missing warning label for inoperative collision mitigation system

    Navistar is recalling certain 2022-2023 IC BUS school buses because the warning label for the inoperative collision mitigation system may be missing. Drivers may not be aware the safety system is not functioning.

    Product
    IC BUS — IC BUS RESB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0778-2022·2022-04-27

    Injectable Drug Recalled Due to Sterility Assurance Concerns

    North American Custom Laboratories is recalling LL-37 2 mg/mL injectable vials due to manufacturing process deviations that raise questions about product sterility. The company distributed 25 vials nationwide.

    Product
    LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0776-2022·2022-04-27

    Injectable Drug Recalled for Sterility Concerns Due to Manufacturing Defects

    North American Custom Laboratories recalls BPC-157 injectable solution due to manufacturing deviations that compromise sterility assurance. The FDA classified this as a Class II recall affecting 778 vials distributed nationwide.

    Product
    BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2022·2022-04-27

    Artis Q floor X-ray system cooling failure poses overheating risk

    Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.

    Product
    Artis Q floor, Model Number 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2022·2022-04-27

    Medical device X-ray imaging system recalled for cooling failure

    Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.

    Product
    Artis Q.zen floor, Model Number 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V282000·2022-04-27

    Commercial buses with inoperative collision system lack required warning label

    Navistar is recalling certain 2022-2023 commercial buses equipped without forward radar units. The required warning label indicating the collision mitigation system is inoperative may be missing, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS HV, MV, RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2022·2022-04-27

    Genetic Testing Kit Recalled for Inaccurate Mutation Test Results

    Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.

    Product
    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Drugs)·D-0777-2022·2022-04-27

    Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations

    North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.

    Product
    Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V279000·2022-04-27

    Blue Bird Recalls 2023 Vision School Buses for Stop Arm Defect

    Blue Bird is recalling 2023 Vision school buses because incorrect pins on the air stop arm may cause it to fail, increasing injury risk during boarding.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2022·2022-04-27

    Medical imaging system software errors may delay treatment procedures

    Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.

    Product
    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2022·2022-04-27

    Medical X-ray imaging system recalled for cooling circuit malfunction

    Siemens' Artis zee X-ray imaging systems may have inadequate cooling if the coolant level drops, potentially causing X-ray tube overheating. The system displays warnings and blocks X-ray operation to prevent equipment damage.

    Product
    Artis zee multi-purpose, Model Number 10094139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2022·2022-04-27

    Artis Q zeego X-ray system recalled for inadequate cooling risk

    Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

    Product
    Artis Q zeego, Model Number 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2022·2022-04-27

    Medical device software defect causes incorrect rotation count in surgical handpiece

    Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0960-2022·2022-04-27

    HUNTLEIGH Disposable Intraoperative Probe recalled for detachable faceplate

    Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) because the faceplate may become detached from the probe body during use.

    Product
    HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0779-2022·2022-04-27

    Melanotan II Injectable Recalled for Manufacturing Sterility Defect

    Melanotan II injection (35 vials) is being recalled nationwide due to manufacturing deviations that could compromise product sterility. Patients should not use affected lots and should contact their healthcare provider.

    Product
    Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V280000·2022-04-27

    Micro Bird Recalls School Buses Due to Insufficient Seat Hardware

    Micro Bird is recalling 2018-2020 MB II school buses because GenQ seats may be attached with insufficient hardware, increasing injury risk in a crash.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0775-2022·2022-04-27

    Injectable Drug Recall: ARA-290 Due to Sterility Manufacturing Defects

    ARA-290 (Cibinetide Acetate) injection is recalled due to manufacturing deviations that call sterility into question. Patients should contact their healthcare provider, as 28 vials have been distributed nationwide.

    Product
    ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1011-2022·2022-04-27

    Miller's Ale House Ice Cream Recalled for Undeclared Allergens

    Specialty Desserts Services is recalling Miller's Ale House Capt. Jack's Buried Treasure ice cream due to failure to declare milk, egg, wheat, soy, almonds, and coconut allergens. Consumers with these allergies should not consume the product.

    Product
    MILLER'S ALE HOUSE, CAPT. JACK'S BURIED TREASURE, Vanilla Ice Cream, Oreo, Heath Bar, Caramel and Hot Fudge. AYE CAPTAIN!
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0780-2022·2022-04-27

    PT-141 Injection Recalled for Sterility Assurance Defect

    PT-141 (Bremelanotide) injection vials are recalled due to manufacturing deviations that compromise sterility assurance. The FDA Class II recall involves 43 vials distributed nationwide.

    Product
    PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1007-2022·2022-04-27

    New England Beach Pizza Recalled for Potential Metal Contamination

    Beach Brand Foods is recalling New England Beach Pizza products due to potential metal contamination. The affected lots include Lot 087 with best-by date 11/09/2022, distributed in New Hampshire and Massachusetts.

    Product
    New England Beach Pizza 1. Extra Cheese 2. Cheese
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0947-2022·2022-04-27

    Matrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection

    Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.

    Product
    Matrix Clinical Solution At-Home COVID-19 Test
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0964-2022·2022-04-27

    Merlin PCS 3650 Programmer May Fail to Terminate Pacing Test Properly

    A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2022·2022-04-27

    FDA recalls Regard IV Start Kit component over safety issue

    Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees in Missouri.

    Product
    Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0965-2022·2022-04-27

    Cardiac Device Programmer Software May Fail to Terminate Test

    St. Jude Medical's Merlin 2 programmer software can fail to stop a clinical Decrement Test and restore pacing parameters during in-clinic testing, affecting 401 devices worldwide.

    Product
    Merlin 2 PCS MER3700 programmer Model MER3400 software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2022·2022-04-27

    Virus Counter Platform VC3100 Class II Medical Device Recall

    Sartorius Corporation is recalling the Virus Counter Platform Model VC3100 (model numbers VIR-92166, VIR-92341) distributed nationwide to 82 units, classified as a Class II FDA medical device recall.

    Product
    Virus Counter Platform with Model Name VC3100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2022·2022-04-27

    Artis zee floor X-ray systems recalled for cooling system failure

    Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.

    Product
    Artis zee floor, Model Number 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V281000·2022-04-27

    Daimler Recalls 2019-2021 Sprinter Vehicles for Rearview Camera Software Error

    Daimler Vans USA is recalling 2019-2021 Freightliner and Mercedes-Benz Sprinter vans because a software error may prevent the rearview camera from displaying an image.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 4500, SPRINTER 1500, SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0781-2022·2022-04-27

    Sermorelin Acetate Injection Recalled Due to Sterility Assurance Issues

    Sermorelin Acetate injectable (76 vials) recalled nationwide due to manufacturing deviations that compromise sterility assurance. No illnesses reported.

    Product
    Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2022·2022-04-27

    Terumo Cardiovascular Procedure Kit Recall for Shipping Damage

    Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.

    Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2022·2022-04-27

    Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

    Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

    Product
    Artis Q.zen biplane, Model Number 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2022·2022-04-27

    Beckman Coulter IRISpec CA Control glucose measurement failures recalled

    Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.

    Product
    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0954-2022·2022-04-27

    Medical Device Reference Standard Recalled for Inadequate Quality Control Process

    Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.

    Product
    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2022·2022-04-27

    Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling

    Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2022·2022-04-27

    Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC

    Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.

    Product
    Inactivated macrolide-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2022·2022-04-27

    X-ray Imaging System Cooling Failure May Cause Tube Overheating

    Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

    Product
    Artis zee ceiling, Model Number 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2022·2022-04-27

    Oral DNA Collection Device Recalled for Evaporating Stabilizing Liquid

    DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.

    Product
    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0982-2022·2022-04-27

    Oral RNA Collection Kit Recalled Due to Stabilizer Evaporation

    DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.

    Product
    ORAcollect RNA: ORE-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2022·2022-04-27

    X-Ray Imaging System Cooling Circuit Failure Recall

    Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

    Product
    Artis zee floor MN, Model Number 10094142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0784-2022·2022-04-27

    Hand Sanitizer Recalled Over Manufacturing Quality Deviations

    VIRGIN SCENT INC has recalled 46,368 bottles of artnaturals Hand Sanitizer nationwide due to manufacturing process deviations. The affected lots were produced using common ingredients from a contaminated batch.

    Product
    artnaturals Hand Sanitizer
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0773-2022·2022-04-27

    Diclofenac Sodium Topical Solution Recalled Due to Manufacturing Quality Deviations

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution because the manufacturing firm discontinued its stability study program, a CGMP violation. All products within their expiration dates are affected.

    Product
    Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0783-2022·2022-04-27

    FDA Recalls artnaturals Scent-Free Hand Sanitizer for Manufacturing Deviations

    artnaturals Scent-Free Hand Sanitizer is recalled due to manufacturing process deviations. Approximately 570,268 bottles distributed nationwide are affected.

    Product
    artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V278000·2022-04-26

    Porsche Taycan seat wire harness defect may deactivate airbags

    Porsche is recalling certain 2020-2021 Taycan vehicles because the driver and passenger seat wire harness could become damaged during horizontal seat adjustment. A damaged harness may deactivate airbags, increasing crash injury risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·011-2022·2022-04-25

    Lakeside Refrigerated Services Recalls Ground Beef Due to E. coli O103 Risk

    Lakeside Refrigerated Services is recalling approximately 120,872 pounds of ground beef products due to possible E. coli O103 contamination. The products were shipped to retail locations nationwide.

    Product
    Lakeside Refrigerated Services Recalls Ground Beef Products Due to Possible E. coli O103 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V277000·2022-04-25

    PACCAR Recalls Kenworth and Peterbilt Trucks for Steering Fastener Defect

    PACCAR is recalling 2018-2020 Kenworth and Peterbilt trucks because steering arm fasteners may fail, potentially causing loss of steering control.

    Product
    KENWORTH — KENWORTH, PETERBILT T270, 579, T440, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V276000·2022-04-25

    Gillig Recalls 2014-2021 Low Floor Buses Due to Engine Start Risk

    Gillig is recalling 2014-2021 Low Floor transit buses because rear-mounted ultracapacitors may allow the engine to start unexpectedly while the master battery disconnect switch is off.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V272000·2022-04-22

    Thomas Built Buses Recalling HDX Models for Battery Cable Fire Risk

    Daimler Trucks North America is recalling 2019-2023 Thomas Built Bus HDX commercial buses because an improperly routed battery cable may chafe and cause an electrical short circuit, increasing the risk of a fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·010-2022·2022-04-22

    Tennessee Brown Bag Recalls Beef Jerky Produced Without Federal Inspection

    Tennessee Brown Bag, LLC is recalling approximately 4,590 pounds of beef jerky produced without federal inspection. Consumers are advised not to consume the products.

    Product
    Tennessee Brown Bag, LLC Recalls Beef Jerky Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    5 states

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