The Recall Desk

Archive

August 2022 recalls

577 recalls were announced in August 2022.

What the numbers show

Critical
6
Severe
89
High
324
Moderate
155
Low
3

Of the 577 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

501–577 of 577

  • SevereNHTSA·22V579000·2022-08-04

    Blue Bird Recalls School Buses Due to Fuel Line Corrosion Risk

    Blue Bird is recalling 2017-2023 Vision school buses with specific LPG conversion systems because fuel line corrosion may cause leaks and fire.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V578000·2022-08-04

    Blue Bird Recalls Vision Buses Due to Fuel Line Fire Risk

    Blue Bird is recalling 2018-2023 Vision buses with specific LPG systems because fuel lines may corrode and leak, increasing fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22196·2022-08-04

    DeWALT 12-inch Sliding Compound Miter Saws Recalled for Injury Hazard

    DeWALT is recalling approximately 1.36 million 12-inch sliding compound miter saws because the rear safety guard can break or detach, creating a risk of projectiles and laceration injuries. Consumers should stop using the saws and contact DeWALT for a free repair.

    Product
    DeWALT 12-inch Sliding Compound Miter Saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V570000·2022-08-04

    Ferrara Fire Trucks Recalled for Potential Steering Gear Fracture

    Ferrara is recalling 2021-2022 Igniter, Cinder, and Inferno fire trucks because incorrectly assembled steering gears may fracture, causing loss of steering control.

    Product
    FERRARA — FERRARA IGNITER, CINDER, INFERNO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V571000·2022-08-04

    Jayco Recalls 2022-2024 Travel Trailers Due to Awning Seam Defect

    Jayco is recalling specific 2022-2024 travel trailers and fifth wheels because a welded seam on the electric retractable awning may separate, causing the awning to drop.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO FIFTH WHEEL JAY FLIGHT SLX, SEISMIC, EAGLE HT, PINNACLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V576000·2022-08-04

    Ditch Witch Trailers Recalled for Incorrect Weight Rating Labels

    Charles Machine Works is recalling 2020-2022 Ditch Witch VT12, VT14, VT24, and VT14MV trailers because the vehicle certification labels list the wrong Gross Axle Weight Rating.

    Product
    DITCH WITCH — DITCH WITCH VT24, VT14, VT14MV, VT12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V577000·2022-08-04

    Altec Recalls 2017-2021 Aerial Devices Due to Wiring Defect

    Altec is recalling 2017-2021 aerial devices because a wire may be damaged by a sharp edge, potentially causing an engine stall and increasing crash risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V582000·2022-08-04

    Kenworth T680 Tractor Trailers Recalled for Fuel Tank Wear Risk

    PACCAR is recalling approximately 630 2022-2023 Kenworth T680 tractor trailers. The mud flap may contact the fuel tank during operation, causing wear that could result in fuel spillage and increase crash or injury risk.

    Product
    KENWORTH — KENWORTH T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V584000·2022-08-04

    Newmar Motorhomes: Improperly Connected LPG Service Valves Risk Propane Leaks

    Newmar is recalling certain 2022 and 2021-2023 motorhomes due to improperly connected LPG service valves that may leak propane. A leak in the presence of an ignition source can increase fire risk.

    Product
    NEWMAR — NEWMAR CANYON STAR, BAY STAR SPORT, KOUNTRY STAR, BAY STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V574000·2022-08-04

    Terex Advance Recalls 2022 Front Discharge Mixers for Engine Control Module Defect

    Terex Advance is recalling 2022 Front Discharge Mixers with Cummins diesel engines because the engine control module may short-circuit, causing unexpected engine shutdowns that increase crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V573000·2022-08-04

    Highland Ridge RV Recalls 2022 Trailers Due to Awning Fabric Defect

    Highland Ridge RV is recalling 2,448 2022 model year trailers because a welded seam on the electric retractable awning fabric may separate, allowing the awning to drop unexpectedly.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW, HIGHLAND RIDGE TT SILVERSTAR XLT, RANGE LITE AIR, OPEN RANGE ROAMER, OLYMPIA SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V572000·2022-08-04

    2022 Starcraft Travel Trailers: Electric Awning Seam Defect

    Starcraft is recalling certain 2022 Autumn Ridge Outfitter, Super Lite, and Super Lite Maxx travel trailers because the electric retractable awning's welded seam may separate, causing the awning to drop.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT SUPER LITE MAXX, SUPER LITE, AUTUMN RIDGE OUTFITTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22197·2022-08-04

    Makita Cordless Hedge Trimmers Recalled for Missing Blade Guard

    Makita U.S.A. Inc. is recalling about 2,600 cordless hedge trimmers because the teal-colored guard on the shear blade may be missing, posing a laceration hazard to users.

    Product
    Cordless hedge trimmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V581000·2022-08-04

    2022 Land Rover Range Rover Velar recall: missing audio amplifier module

    Certain 2022 Land Rover Range Rover Velar vehicles were manufactured without an Audio Amplifier Module, causing loss of critical safety features including seat belt reminders and ADAS warnings. Owners should contact Land Rover at 1-800-637-6837 for free repair.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER VELAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V583000·2022-08-04

    2022-2023 Newmar Motorhomes Recalled for Fuel Line Fire Risk

    Newmar Corporation is recalling certain 2022-2023 motorhomes with International Thermal Research heaters due to incorrectly installed fuel lines that may leak and create a fire hazard.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, DUTCH STAR, ESSEX, NEW AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V575000·2022-08-04

    Jayco Recalls 2022 RVs Due to Awning Fabric Seam Separation Risk

    Jayco is recalling 2022 Greyhawk, Melbourne, Redhawk, and Entegra Odyssey RVs because a welded seam on the electric awning fabric may separate, allowing the awning to drop and increase injury risk.

    Product
    JAYCO — JAYCO, ENTEGRA GREYHAWK, ODYSSEY, REDHAWK, MELBOURNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1292-2022·2022-08-03

    Insulin Glargine Prefilled Pens Recalled for Missing Label

    Mylan Pharmaceuticals is recalling Insulin Glargine prefilled pens (lot BF21002895) distributed nationwide because some pens lack labels, which could prevent patients from properly identifying and administering the medication.

    Product
    Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specia
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1397-2022·2022-08-03

    BD Intraosseous Needle Kits recalled for mechanical failure and safety defects

    BD Intraosseous Needle Kits have been recalled due to mechanical failures that could prevent emergency vascular access. Affected units nationwide and in Canada may experience stylet removal problems, safety mechanism failures, or driver malfunction.

    Product
    Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1286-2022·2022-08-03

    Nifedipine WSP Ointment Recalled Due to Potency Variability

    Valor Compounding Pharmacy is recalling Nifedipine WSP 0.2% Ointment due to potency variability. Some batches may be subpotent or superpotent, affecting safety and efficacy.

    Product
    Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1395-2022·2022-08-03

    CereLink ICP Monitor recalled for out-of-range pressure readings

    Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.

    Product
    CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1507-2022·2022-08-03

    Za'atar Seasoning recalled for potential Salmonella in oregano

    Fuchs North America is recalling Za'atar Seasoning (lot 252491) because an oregano sub-ingredient tested positive for Salmonella. The product was distributed to one commercial buyer.

    Product
    Za'atar Seasoning, Cust Part # Lot No. 252491, NET WT 50 lbs bag in a box. One bag per box, GT 74862, Lot code: 252491.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1376-2022·2022-08-03

    ABACUS TPN Calculation Software recalled for medication error risk

    Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.

    Product
    ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·22V566000·2022-08-03

    Kalmar Recalls 2021-2022 Ottawa T2 Tractors Due to Steering Gear Defect

    Kalmar is recalling 2021-2022 Ottawa T2 terminal tractors because incorrectly assembled steering gears may fracture, causing loss of steering control and increasing crash risk.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V567000·2022-08-03

    Audi Recalls One 2022 SQ5 Sportback for Rear Lid Connection Issue

    Volkswagen Group of America is recalling one 2022 Audi SQ5 Sportback because the rear lid connections may be improper, potentially reducing crash protection.

    Product
    AUDI — AUDI SQ5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2022·2022-08-03

    Medline Medical Kits Recalled for Leaking Isopropyl Alcohol

    Medline convenience kits containing leaking bottles of isopropyl alcohol are being recalled. Approximately 477 units were distributed nationwide and should not be used.

    Product
    Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2022·2022-08-03

    Blood Glucose Meter Recalled for Marketing Without FDA Clearance

    Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.

    Product
    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1291-2022·2022-08-03

    FDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Sun Pharmaceutical recalls Divalproex Sodium delayed-release tablets due to failed dissolution specifications discovered during stability testing. The tablets may not dissolve as intended.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1287-2022·2022-08-03

    Lansoprazole tablets recalled nationwide due to failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Lansoprazole 15-mg delayed-release tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2022·2022-08-03

    Medline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles

    Medline has recalled custom neurosurgical procedure kits nationwide due to leaking bottles of isopropyl alcohol. The leakage poses a risk of contamination and chemical exposure during surgical procedures.

    Product
    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2022·2022-08-03

    TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure

    Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.

    Product
    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1508-2022·2022-08-03

    Bumble Bee Smoked Clams recalled for detectable PFAS contamination

    Bumble Bee Smoked Clams (3.75 oz) are recalled due to detectable levels of per- and polyfluoroalkyl substances (PFAS). The recall affects U.S. distribution to 13 states.

    Product
    Bumble Bee Smoked Clams Shucked Easy Open NET WT. 3.75 oz. (106 g) Distributed By: Bumble Bee Seafoods San Diego, CA 92186 USA Product of China UPC 0 86600 75234 1
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1512-2022·2022-08-03

    Dole Spring Mix Recalled for Potential Hairy Nightshade Contamination

    Dole Fresh Vegetables is recalling Simply Nature Organic Spring Mix and Marketside Spring Mix due to potential contamination with hairy nightshade. The recalled products were distributed to Ohio, Illinois, Indiana, and Tennessee.

    Product
    Simply Nature Organic Spring Mix 16 oz. Marketside Spring Mix 11 oz. and 5 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-1294-2022·2022-08-03

    Jubilant Cadista Irbesartan tablets recalled due to failed dissolution

    Jubilant Cadista Pharmaceuticals is recalling 28,560 bottles of Irbesartan 75 mg tablets nationwide due to failed dissolution specifications that may compromise drug efficacy.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1293-2022·2022-08-03

    Irbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution

    Jubilant Cadista is recalling 9,600 bottles of Irbesartan Tablets (150mg) nationwide due to failed dissolution specifications. Affected lot IB220023A expires 08/2022.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2022·2022-08-03

    GE Centricity PACS Software fails to notify of exam study modifications

    GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.

    Product
    Centricity PACS Software Version 7.0 SP0.0.4.7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2022·2022-08-03

    Hematology Analyzer Sight OLO Displays Incorrect Pediatric Reference Ranges

    The Sight OLO automated hematology analyzer displays mixed-up default reference ranges for children ages 2-11 in software versions 2.63, 2.63.1, and 2.63.1.1, which could cause test results to appear incorrectly normal or abnormal.

    Product
    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2022·2022-08-03

    Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles

    Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.

    Product
    Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2022·2022-08-03

    Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results

    Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.

    Product
    REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1475-2022·2022-08-03

    Medline skin prep kits recalled due to leaking isopropyl alcohol bottles

    Medline Industries is recalling 1,880 units of skin prep convenience kits with models DYNDP1127A and DYNDP1131 distributed nationwide due to leaking bottles of isopropyl alcohol.

    Product
    Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1459-2022·2022-08-03

    Da Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion

    Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.

    Product
    Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2022·2022-08-03

    AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk

    Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.

    Product
    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2022·2022-08-03

    Medical Device Kits Recalled for Leaking Isopropyl Alcohol

    Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.

    Product
    Z-1477-2022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2022·2022-08-03

    Stryker Craniotomy Router May Break and Leave Metal Fragments

    Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.

    Product
    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2022·2022-08-03

    Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol

    Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.

    Product
    Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2022·2022-08-03

    Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol

    Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.

    Product
    Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2022·2022-08-03

    NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information

    NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.

    Product
    Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1510-2022·2022-08-03

    Just Egg Spring Greens Recalled for Listeria monocytogenes Contamination

    Eat Just, Inc. is recalling Just Egg Spring Greens due to potential Listeria monocytogenes contamination. The affected product was distributed in California, Georgia, and Texas.

    Product
    Just Egg Spring Greens Broccoli, Peas, Spinach, Kale, Basil, Dill Chopped plant egg NET WT 12 OZ (340g) UPC 1 91011 00101 5 Distributed by Eat Just, Inc. Alameda, CA 94501 Made in Canada
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1289-2022·2022-08-03

    Prescription testosterone gel recalled due to out-of-specification potency

    Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2022·2022-08-03

    Dialysis Machine Recalled for Electrical Shock Risk in AquaC UNO H

    The FDA is recalling 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.

    Product
    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2022·2022-08-03

    Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect

    Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2022·2022-08-03

    Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results

    Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.

    Product
    REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1468-2022·2022-08-03

    HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating

    Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.

    Product
    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2022·2022-08-03

    Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results

    Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.

    Product
    REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1471-2022·2022-08-03

    Medline medical device kits recalled for leaking isopropyl alcohol bottles

    Medline Industries is recalling medical convenience kits containing leaking bottles of isopropyl alcohol due to chemical exposure risk. The recall affects 288 units distributed nationwide.

    Product
    Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2022·2022-08-03

    Medical imaging software may flip left-right brain image orientation

    NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.

    Product
    nordicBrainEX, software versions 2.21 through 2.3.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2022·2022-08-03

    X-Stream Irrigation System recalled due to potential fire hazard

    Davol, Inc. is recalling the X-Stream Irrigation System due to a potential fire hazard. The device may cause a fire during use, creating a safety risk.

    Product
    X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2022·2022-08-03

    Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion

    Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.

    Product
    Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2022·2022-08-03

    Revogene diagnostic test instrument recalled for burn risk from cooling failure

    Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.

    Product
    Revogene, Catalog no. 610210. IVD test instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1290-2022·2022-08-03

    Crest 3D White Toothpaste recalled for missing label and wrong formulation

    Procter & Gamble is recalling Crest 3D White Fluoride Anticavity Toothpaste because some tubes lack labels and contain a different formulation than indicated. About 1,128 tubes distributed in Washington State are affected.

    Product
    Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1458-2022·2022-08-03

    Paragon 28 Gorilla Plating System Drill Recalled for Incorrect Packaging Label

    Paragon 28, Inc. has recalled Baby Gorilla/Gorilla Plating System drills (Ref: P99-100-2816) because the drill packaging may contain incorrect part numbers.

    Product
    Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1298-2022·2022-08-03

    Juice Beauty Lip Moisturizer recalled for failed dissolution specifications

    Eco Lips, Inc. is recalling Juice Beauty The Organic Solution SPF 8 Joyful Lip Moisturizer (15,313 tubes) because the product failed dissolution specifications. Affected units were distributed in California.

    Product
    Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1509-2022·2022-08-03

    Lee Ann Chin Thai Peanut Sauce Recalled for Elevated pH Levels

    Lee Ann Chin Thai Peanut Sauce in 13.5 oz bottles is recalled because the sauce has pH levels higher than product specifications. The recall affects products distributed in Minnesota and Wisconsin.

    Product
    Lee Ann Chin Thai Peanut Sauce. In glass botle. Net Wt 13.5 oz (384g) UPC 61248 87100. Shake Well. Refrigerate After Opening. Lee Ann Chin, Bloomington, MN 55431
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-1299-2022·2022-08-03

    Juice Beauty lip moisturizer recalled for failed dissolution specifications

    Juice Beauty The Organic Solution SPF 8 lip moisturizer is being recalled due to failed dissolution specifications. The recall affects 35,313 tubes distributed in California.

    Product
    Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1465-2022·2022-08-03

    ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label

    Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.

    Product
    ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V565000·2022-08-02

    Travel Trailers Recalled for Improperly Tightened Axle Bolts

    Xtreme Outdoors is recalling 2021-2022 Little Guy Max and Mini Max travel trailers with improperly tightened axle bolts that could cause axle detachment and increase crash risk.

    Product
    XTREME OUTDOORS — XTREME OUTDOORS LITTLE GUY MINI MAX, LITTLE GUY MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V564000·2022-08-02

    Delco Trailers Recalls 2021-2022 Models Due to Axle Weld Defect

    Delco Trailers is recalling 2021-2022 C, D, and F-Series trailers because a defective axle weld may crack or separate, increasing crash risk.

    Product
    DELCO TRAILERS — DELCO TRAILERS C-SERIES, F-SERIES, D-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V562000·2022-08-02

    Forest River Wildwood awning rail may detach while in motion

    Forest River is recalling certain 2021-2022 Wildwood and Salem fifth wheel trailers. The awning rail may detach while the vehicle is in motion, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V563000·2022-08-02

    2021 Mitsubishi Outlander Sport CVT transmission software defect causes engine stall

    Mitsubishi is recalling 2019-2022 Outlander Sport vehicles for a software error in the transmission control unit that may cause engine stall at high speeds, increasing crash risk. Approximately 76,508 vehicles are affected.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V558000·2022-08-01

    Forest River Rockwood and Flagstaff tent campers recalled for defective brake axle

    Forest River is recalling certain 2022 Flagstaff and 2022-2023 Rockwood tent campers due to improperly installed axles that can reduce brake function. Owners should contact their dealer for free inspection and repair.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V559000·2022-08-01

    Coachmen V-TREC Camping Trailers: Defective Pull-Out Bunk Beds

    Forest River is recalling certain 2022 Coachmen camping trailers with improperly laminated pull-out bunk beds that may not support weight as intended. The defective bunks could collapse during use, increasing the risk of injury.

    Product
    COACHMEN — COACHMEN CLIPPER, V-TREC, VIKING
    Category
    Vehicle
    Distribution
    Distributed nationwide

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