The Recall Desk

Archive

July 2022 recalls

561 recalls were announced in July 2022.

What the numbers show

Critical
6
Severe
96
High
416
Moderate
40
Low
3

Of the 561 recalls this month scored against our rubric, 1% are Critical, 17% are Severe.

501–561 of 561

  • SevereFDA (Food)·F-1368-2022·2022-07-06

    Fudgeamentals Peanut Butter Fudge Bites Recalled for Salmonella Contamination

    Fudgeamentals is recalling Peanut Butter Fudge Bites nationwide due to Salmonella contamination in the peanut butter ingredient. Consumers should not consume the affected product.

    Product
    PEANUT BUTTER FUDGE BITES (24-8 OZ) FUDGEAMENTALS
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1362-2022·2022-07-06

    Snack Sensations Apple, Pretzel & Celery Bites Recalled for Salmonella

    Stellex/CF Houston, LLC is recalling Snack Sensations Apple, Pretzel & Celery Bites with Peanut Butter due to potential Salmonella contamination. The product was distributed across multiple states from May 2021 to June 2022.

    Product
    Snack Sensations Apple, Pretzel & Celery Bites with Peanut Butter Net Wt. 4 oz. packed in clear non-flexible plastic package UPC 0 74641 07336 5
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1365-2022·2022-07-06

    Peanut Butter Chocolate Fudge Bars Recalled Due to Salmonella Contamination

    Fudgeamentals LLC is recalling Peanut Butter Chocolate Fudge Bars (8 oz.) due to Salmonella contamination in the peanut butter ingredient. 189,096 units were affected nationwide.

    Product
    PEANUT BUTTER CHOCOLATE FUDGE BAR - 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1165-2022·2022-07-06

    SnoreStop NasoSpray nasal spray recalled for bacterial contamination

    SnoreStop NasoSpray nasal spray has been recalled due to bacterial contamination. FDA analysis identified Providencia rettgeri in the product.

    Product
    SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1371-2022·2022-07-06

    Fudgeamentals Tiger Butter Fudge Bar Recalled for Salmonella

    Fudgeamentals LLC is recalling Tiger Butter Fudge Bar (8 oz) nationwide due to Salmonella contamination in the peanut butter ingredient. Affected lot codes: 22059007, 22083006, 22089006, 22130394.

    Product
    Fudgeamentals TIGER BUTTER FUDGE BAR (8 OZ)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1366-2022·2022-07-06

    Chocolate Variety Tray Recalled for Salmonella Contamination in Peanut Butter

    Fudgeamentals Variety Tray (16 oz) is being recalled nationwide due to Salmonella contamination in its peanut butter component. Consumers should not consume the product and should discard it.

    Product
    VARIETY TRAY (16 OZ) (C-CNC-PBC) FUDGEAMENTALS
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1370-2022·2022-07-06

    Fudge Trio Holiday Fudge Tray Recalled Nationwide for Salmonella Contamination

    Fudgeamentals LLC is recalling Marketside and Walmart Fudge Trio Holiday Fudge Trays nationwide due to Salmonella contamination in the peanut butter ingredient. Consumers should discard these products and not consume them.

    Product
    1. Marketside FUDGE TRIO HOLIDAY FUDGE TRAY - 16 oz. 2. WALMART MKT FUDGE TRIO (6-16 OZ) HOLIDAY FUDGE TRAY FUDGEAMENTALS
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2022·2022-07-06

    TEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager

    Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.

    Product
    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2022·2022-07-06

    Anesthesia device backup batteries may fail prematurely, GE Healthcare recalls

    GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.

    Product
    Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2022·2022-07-06

    Radiation therapy software shows misleading dose display in RayStation 11B

    RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.

    Product
    RayStation 11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2022·2022-07-06

    Atrium Firm PVC Thoracic Catheter Recall Due to Expiration Date Mismatch

    Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French due to an expiration date mismatch between the sterile barrier pouch and case labels. The discrepancy allowed product to be used up to five days past its true expiration date.

    Product
    Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1384-2022·2022-07-06

    Wilton Rainbow Sprinkles Mix recalled for milk contamination

    Wilton Industries recalled 16,281 units of Wilton Rainbow Sprinkles Mix due to milk contamination. The affected lots are 21005Z and 21111Z.

    Product
    Wilton Rainbow Sprinkles Mix net wt 5.92 oz. item number 710-0-0627
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1382-2022·2022-07-06

    Key lime cookies recalled for undeclared soy and sulfite allergens

    Be Happy Cakes is recalling Kristi's Key Lime Cookies because they contain undeclared soy and sulfite allergens. Consumers allergic to soy or sulfites should not consume this product.

    Product
    Kristi's Key Lime Cookies, A Florida Original
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1383-2022·2022-07-06

    Boar's Head Spinach Greek Yogurt Dip recalled due to plastic contamination

    Klondike Cheese Company is recalling Boar's Head Brand Spinach Greek Yogurt Dip due to plastic foreign objects. The recall affects specific lot numbers distributed in Florida.

    Product
    Boar's Head Brand Spinach Greek Yogurt Dip. packaged in plastic container with lid. Net Wt. 12oz. UPC 42421-16282. Keep Refrigerated. Distributed by: Brunckhorst Co., NY, NY 11206-3886.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1385-2022·2022-07-06

    Wilton Rainbow Chip Crunch Sprinkles recalled due to milk contamination

    Wilton Industries is recalling Rainbow Chip Crunch Sprinkles (5.25 oz) due to milk contamination. The recall affects 6,400 units distributed nationwide and internationally.

    Product
    Wilton Rainbow Chip Crunch Sprinkles net wt 5.25 oz. item 710-5364
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2022·2022-07-06

    Stryker INFINITY Resect Guide Recalled for Incorrect Color Coding

    Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.

    Product
    Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V464000·2022-07-06

    Cummins Recalls 2020-2022 Trailer-Mounted Generator Sets Due to Shutdown Defect

    Cummins is recalling 2020-2022 C500D6Re trailer-mounted generator sets because a logic error may prevent them from shutting down, posing burn and shock risks.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V480000·2022-07-06

    Toyota 4Runner 2020-2022 Incorrect Tire Load Capacity Labels

    Southeast Toyota Distributors is recalling 2020-2022 Toyota 4Runners with 20-inch Black Gunner Wheels due to incorrect load capacity labels that could lead to vehicle overloading and increased crash risk.

    Product
    TOYOTA — TOYOTA 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V476000·2022-07-06

    2021–2022 Cargo trailers recalled for defective safety chains

    Forest River is recalling certain 2021–2022 Cargo Mate and Continental Cargo Trailers because safety chains don't meet weight rating specifications. A chain failure could cause the trailer to detach from the tow vehicle, increasing crash risk.

    Product
    CONTINENTAL CARGO — CONTINENTAL CARGO, CARGO MATE CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1164-2022·2022-07-06

    FDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1372-2022·2022-07-06

    Walnut Product Misidentified as Nutritional Yeast Due to Labeling Error

    Honey Heaven Wholesale Inc is recalling 48 bags of walnut product labeled as Nutritional Yeast due to mislabeling. The misidentification poses a potential allergen risk to consumers with tree nut allergies.

    Product
    The content inside package is walnut but was mis-labeled as Nutritional Yeast and packaged in a stand up plastic pouch. Net Weight: 0.6lb (272g). UPC: 616316762060 The label is read in parts: "***Brand Name: Hummingbird ***Organic Nutritional Yeast Large Flake***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1295-2022·2022-07-06

    CV Minor Kit with Nonsterile Component Recalled for Contamination Risk

    ROi CPS LLC is recalling 180 CV Minor Kit units due to a nonsterile component accidentally packaged in the sterile kit, posing a contamination and infection risk.

    Product
    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2022·2022-07-06

    Central venous catheter recalled for incorrect gravity flow rates

    Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.

    Product
    Arrow Three-Lumen CVC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2022·2022-07-06

    Artis Pheno fluoroscopic system may lose video display signals

    Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.

    Product
    Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1387-2022·2022-07-06

    PurAqua Belle Vie Sparkling Water Recalled for Undeclared Caffeine

    PurAqua Belle Vie Sparkling Water with Ashwagandha contains undeclared caffeine. The product was distributed to 17 states and poses potential risk for caffeine-sensitive consumers.

    Product
    PurAqua Belle Vie SPARKLING WATER wellness RELAX 100mg ASHWAGANDHA PER 12 FL OZ STRAWBERRY CUCUMBER FLAVORED SPARKLING WATER WITH OTHER NATURAL FLAVORS 12 FL OZ (355mL) CAN UPC: 4099100315622
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·F-1386-2022·2022-07-06

    BBQ Sauce Mislabeled as Vegan Despite Containing Fish Allergen

    Blue Kuna BBQ Sauce labeled as vegan contains anchovies (fish), a common allergen. This mislabeling poses a risk to consumers with fish allergies.

    Product
    Blue Kuna Taste of Devil's Night Heat Infused BBQ Sauce, 16 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1172-2022·2022-07-06

    Fluticasone Propionate Nasal Spray Recalled Due to Defective Container

    Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray nationwide due to a defective container that prevents proper dispensing. Patients should contact their healthcare provider or pharmacist.

    Product
    Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1163-2022·2022-07-06

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1169-2022·2022-07-06

    Methylphenidate Patch Recall: Defective Delivery System and Adhesive Issues

    Daytrana (methylphenidate) patches are being recalled due to ripping patches and poor adhesive transfer affecting drug delivery. This Class II recall involves 8,559 cartons distributed nationwide.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1161-2022·2022-07-06

    Losartan Potassium Tablets Recalled for Manufacturing Impurity Issues

    PD-Rx Pharmaceuticals recalls Losartan Potassium Tablets (25 mg, 90-tablet bottles) due to Current Good Manufacturing Practice deviations. Specific lot numbers contain AZIDO impurity levels above acceptable limits.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2022·2022-07-06

    Alphenix 4D CT system may stop operating due to system error

    The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.

    Product
    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1292-2022·2022-07-06

    Medical Device App Records Inaccurate Urinary Flow When Hearing Aids Active

    The ProudP Everyday Uroflow Tracker app may record lower-than-actual urination measurements when a hearing aid or AirPods Live Listen feature is active on the same iPhone, due to interference with the app's sound-based measurement system.

    Product
    ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2022·2022-07-06

    Surgical Light Paint Particles May Fall Into Operating Field

    Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.

    Product
    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2022·2022-07-06

    NaviCare Nurse Call System Cancels Patient Calls During Wireless Use

    The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.

    Product
    NaviCare Nurse Call/Voalte Nurse Call
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2022·2022-07-06

    FDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges

    Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.

    Product
    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2022·2022-07-06

    Orthopedic Plates Recalled Due to Incorrect Etching and Mislabeling

    One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.

    Product
    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2022·2022-07-06

    HydroSurg Plus Laparoscopic Irrigator recalled for inability to irrigate

    Davol HydroSurg Plus Laparoscopic Irrigators cannot provide irrigation. The FDA issued a Class II recall affecting 4,780 units worldwide.

    Product
    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2022·2022-07-06

    Yukon Straight Rod spinal implants recalled for discoloration and contamination

    K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.

    Product
    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1284-2022·2022-07-06

    Tacrolimus Calibrator Set Recalled for Inaccurate Immunoassay Quantitation

    The QMS Tacrolimus Calibrator Set is recalled because calibrators recovered 82-94% of target values, causing inaccurate (over-quantitated) patient drug test results. This affects healthcare facilities in 20 US states and 9 countries.

    Product
    QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1296-2022·2022-07-06

    SOLTIVE SuperPulsed Laser Fibers recalled for model and size labeling mismatch

    Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1162-2022·2022-07-06

    Losartan Potassium tablets recalled for elevated AZIDO impurity

    PD-Rx Pharmaceuticals recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1287-2022·2022-07-06

    Medline Pill Splitters recalled for unhinged lid exposing sharp blade

    Medline is recalling over 840,000 pill splitters due to a defect where the product lid can come unhinged, exposing a sharp blade and posing a laceration risk.

    Product
    Medline Pill Splitters; 1 each/box; 144 boxes/carton
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2022·2022-07-06

    GCX Channel Mounting Accessory Screws May Loosen or Pull Out

    Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.

    Product
    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2022·2022-07-06

    Backup batteries in Avance CS2 anesthesia machines fail prematurely

    GE Healthcare is recalling backup batteries in Avance CS2 and CS2 Pro anesthesia machines manufactured after April 1, 2019. Batteries may fail earlier than expected, affecting approximately 6,600 devices worldwide.

    Product
    Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2022·2022-07-06

    Laparoscopic irrigator recalled for inability to provide irrigation

    Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.

    Product
    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1170-2022·2022-07-06

    Calcipotriene Scalp Solution Recalled Due to Defective Delivery System

    Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.

    Product
    Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2022·2022-07-06

    IVUS Catheter Recall: Missing Contraindications in Instructions

    Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2022·2022-07-06

    FDA recalls MAC laryngoscope sets due to packaging error

    Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.

    Product
    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1303-2022·2022-07-06

    Fresenius Optiflux 200NRe Dialyzers Recalled Due to Temperature Exposure

    Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.

    Product
    Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1302-2022·2022-07-06

    Digital IVUS Catheter Recalled for Missing Contraindication Information

    Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V472000·2022-07-01

    Silver Eagle Recalls 2021 VAST-20W Trailer Converter Dollies

    Silver Eagle is recalling 2021 VAST-20W trailer converter dollies because a ballast hanger may fail and fall onto the roadway, creating a road hazard.

    Product
    SILVER EAGLE — SILVER EAGLE VAST-20W
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V467000·2022-07-01

    Mercedes-Benz Recalls 2022 EQS Models for Bumper Tow Ring Defect

    Mercedes-Benz is recalling 2022 EQS 450, EQS 580, and AMG EQS 53 vehicles because the bumper tow ring assembly may detach, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580, EQS 450, AMG EQS 53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V475000·2022-07-01

    Autocar Recalls 2022-2023 Trucks Due to Steering Gear Fracture Risk

    Autocar is recalling 2022-2023 Legend, Xpeditor, and Xspotter trucks because incorrectly assembled steering gears may fracture, causing loss of steering control.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, XSPOTTER, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V466000·2022-07-01

    Mercedes-Benz Recalls 2020 GLS Models for Front Air Bag Wiring Defect

    Mercedes-Benz is recalling 2020 GLS 450 and GLS 580 vehicles because the front air bag wiring harness may be routed incorrectly, potentially preventing proper air bag deployment in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC, GLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V471000·2022-07-01

    Audi Recalls A4 and A8 Models for Airbag Inflator Defect

    Audi is recalling 1997-1998 A4 and 1998 A8 vehicles because the driver's airbag inflator may explode or underinflate, posing a risk of injury.

    Product
    AUDI — AUDI A4, A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V473000·2022-07-01

    2022 Subaru Outback Engine Wiring Harness Damage Causes Stall Risk

    The engine wiring harness may be damaged in 2022 Subaru Outback vehicles, causing a loose connection to the engine control unit. This could cause engine stalls and increase crash risk.

    Product
    SUBARU — SUBARU OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V474000·2022-07-01

    2022 Oliver Legacy Elite II Travel Trailer Bearing Washer Recall

    The 2022 Oliver Travel Trailers Legacy Elite II may have a cracked bearing washer in the hub assembly that could cause the hub to separate from the axle, risking loss of vehicle control. Owners should contact Oliver at 1-866-205-2621 for a free replacement.

    Product
    OLIVER TRAVEL TRAILERS — OLIVER TRAVEL TRAILERS LEGACY ELITE II
    Category
    Vehicle
    Distribution
    Distributed nationwide

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