The Recall Desk

Archive

May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical
15
Severe
132
High
528
Moderate
72
Low
7

Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

Which agencies issued them

201–300 of 754

  • ModerateFDA (Drugs)·D-0767-2023·2023-05-31

    Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.

    Product
    Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0940-2023·2023-05-31

    Dietary Supplement TruCONTROL Recalled Due to Unapproved Ingredients

    TruVision Health's truCONTROL 60 Count dietary supplement is being recalled because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.

    Product
    truCONTROL 60 Count
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Drugs)·D-0768-2023·2023-05-31

    Fentanyl Buccal Tablets 400mcg missing or incorrect package insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.

    Product
    Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2023·2023-05-31

    Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations

    Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2023·2023-05-31

    Fluoroscopic imaging system may display incorrect radiation dose readings

    Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.

    Product
    Luminos Agile Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0766-2023·2023-05-31

    Fentanyl Buccal Tablets recalled due to missing or incorrect package insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.

    Product
    Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0770-2023·2023-05-31

    Fentanyl buccal tablets recalled due to incorrect or missing package insert

    Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.

    Product
    Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0756-2023·2023-05-31

    Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error

    Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.

    Product
    Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0769-2023·2023-05-31

    Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.

    Product
    Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V384000·2023-05-30

    2023 Toyota Corolla Cross instrument panel airbag deployment risk

    Toyota is recalling 2022-2023 Corolla Cross vehicles because the instrument panel may lack required perforations, preventing proper front-passenger airbag deployment in a crash.

    Product
    TOYOTA — TOYOTA COROLLA CROSS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V382000·2023-05-30

    Alfa Romeo Giulia and Stelvio Recalled for Brake Rotor Fracture Risk

    NHTSA is recalling 2017-2020 Alfa Romeo Giulia and 2018-2020 Stelvio vehicles with carbon ceramic brakes due to a risk of rotor fracture and decreased brake performance.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA, STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V378000·2023-05-26

    Ford Recalls 2015-2019 Lincoln MKC for Engine Compartment Fire Risk

    Ford is recalling 2015-2019 Lincoln MKC vehicles because a battery monitor sensor may short-circuit and overheat, causing a fire in the engine compartment.

    Product
    LINCOLN — LINCOLN MKC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V381000·2023-05-26

    Knapheide Recalls Vehicles with Warn Winches Due to Unintentional Operation Risk

    Knapheide is recalling 2022-2023 trucks equipped with certain Warn winches because water intrusion can cause the winch to operate unintentionally, increasing injury risk.

    Product
    KNAPHEIDE — KNAPHEIDE RAM 3500, FORD F-350, FORD F-250, FORD F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V379000·2023-05-26

    Ford Vehicles Recalled for Incorrect Tire and Loading Capacity Label

    Ford is recalling certain 2019-2023 Ranger, 2022-2023 Bronco, and 2023 F-250 SD vehicles with TREAD labels stating incorrect load carrying capacity, which could result in vehicle overload and increase crash risk.

    Product
    FORD — FORD F-250 SD, RANGER, BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V375000·2023-05-26

    Forest River Recalls 2023 East to West Travel Trailers Due to Gas Leak Risk

    Forest River is recalling 2023 East to West Della Terra and Silver Lake travel trailers because an incorrectly installed furnace may cause a gas leak inside the cabin.

    Product
    EAST TO WEST — EAST TO WEST DELLA TERRA, SILVER LAKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V376000·2023-05-26

    Travel trailers recalled for missing wardrobe cabinet backer board

    Certain 2021-2023 Keystone Arcadia travel trailers lack a backer board behind the wardrobe cabinet, potentially allowing the slide room to extend and cause injury. Dealers will install steel brackets to secure the slide room at no cost.

    Product
    KEYSTONE — KEYSTONE ARCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V380000·2023-05-26

    Ford Escape, Maverick, and Corsair Engine Fire Risk Recall

    Ford is recalling certain 2020-2023 Escape, 2022-2023 Maverick, and 2021-2023 Corsair vehicles due to a 2.5L engine defect that could cause an engine compartment fire. No injuries have been reported.

    Product
    FORD — FORD, LINCOLN MAVERICK, CORSAIR, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V373000·2023-05-25

    2021-2023 Autocar Xpeditor trucks recalled for defective door latch

    Autocar is recalling 2021-2023 Xpeditor commercial trucks due to incorrectly assembled right-side door latches that may open unexpectedly during operation. Owners should contact Autocar for a free inspection and reassembly.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V371000·2023-05-25

    IC Bus school buses recalled for ABS warning light failure

    IC Bus school buses (2021–2024) are being recalled because the anti-lock brake system warning light fails to illuminate during malfunctions, preventing drivers from being alerted and increasing crash risk.

    Product
    IC BUS — IC BUS CESB, RESB, EVSB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V370000·2023-05-25

    2022-2024 International Trucks: ABS Warning Light Fails to Illuminate

    Navistar is recalling certain 2021-2024 International trucks and buses whose anti-lock brake system warning light fails to illuminate when malfunctions occur. Drivers will not be alerted to brake system problems, increasing the risk of crashes.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS LONESTAR, RH, LT, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23761·2023-05-25

    Bunch Bikes Recalls The Preschool Electric Bicycles Due to Excess Lead Paint

    Bunch Bikes is recalling about 150 units of The Preschool Electric Bicycles sold online from April 2020 through December 2022 because the paint contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    The Preschool Electric Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23210·2023-05-25

    Janod Sweet Cocoon Activity Tables Recalled for Choking Hazard

    Juratoys is recalling about 5,080 Janod Sweet Cocoon Activity Tables because a detachable silver metal bell poses a choking hazard to children 12 months and older. Consumers should stop using the tables and contact Juratoys for a free repair kit.

    Product
    Janod Sweet Cocoon Activity Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V368000·2023-05-25

    Fontaine Recalls 2023-2024 Container Trailers Due to Missing Reflectors

    Fontaine Trailer Company is recalling 2023-2024 40-foot container trailers because they may be missing rear reflex reflectors, which reduces visibility and increases crash risk.

    Product
    FONTAINE — FONTAINE CONTAINER TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V374000·2023-05-25

    2023 Nissan Rogue rear seat belt fasteners may loosen in crashes

    Certain 2023 Nissan Rogue vehicles have rear seat belt anchor fasteners that may not have been properly tightened and could loosen over time, potentially failing to restrain occupants in a crash.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V369000·2023-05-25

    Jaguar I-PACE Battery Overheat May Increase Fire Risk

    Jaguar is recalling certain 2019-2024 I-PACE vehicles because the high-voltage battery may overheat, increasing the risk of fire. Owners should park and charge vehicles outside until repairs are complete.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V367000·2023-05-25

    2023 Cadillac Lyriq Battery Connection Defect May Cause Loss of Drive Power

    General Motors is recalling certain 2023 Cadillac Lyriq and 2022 GMC Hummer EV vehicles. Connections in the high-voltage battery pack may be out of position or incorrectly welded, potentially causing loss of drive power and increasing crash risk.

    Product
    CADILLAC — CADILLAC, GMC LYRIQ, HUMMER EV PICKUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23762·2023-05-25

    The Good and the Beautiful Math Boxes Recalled Due to Laceration Hazard

    The Good and the Beautiful is recalling Math 1 and Math 3 boxes with metallic whiteboards because the attached whiteboards can detach and cause lacerations. Four minor laceration injuries have been reported.

    Product
    The Good and the Beautiful Math 1 and Math 3 Boxes with metallic whiteboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0920-2023·2023-05-24

    Gold Medal Flour Recalled Nationwide for Potential Salmonella Contamination

    General Mills is recalling Gold Medal Bleached All Purpose Flour nationwide due to potential Salmonella contamination. Approximately 271,454 bags are affected.

    Product
    Gold Medal Bleached All Purpose Flour, Enriched, Presifted, packaged in the following sizes: 1. Net Wt 32 oz (2lb) 907g, UPC 0 16000-10710 6; and 2. Net Wt 5lb (2.26kg), UPC 0 16000-10610 9. Dist. By General Mills Sales, Inc., Minneapolis, MN 55440.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0893-2023·2023-05-24

    SW Texas Nut Blend Recalled for Undeclared Almonds and Cashews

    SW Texas Nut Blend (Item #5180819) is being recalled due to undeclared almonds and cashews. The product label lists only hazelnuts and walnuts as ingredients.

    Product
    SW Texas Nut Blend, Item #5180819, Packed in cardboard box with poly liner; net wt. 25 lbs. No UPC. Label declares: SW Texas Nut Blend, ingredients: Hazelnuts, Walnuts. Manufactured by: Ardent Mills Ave. Tualatin, OR.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0885-2023·2023-05-24

    Highkey Soft Baked Mini Treats recalled for undeclared egg allergen

    Highkey Soft Baked Mini Treats Birthday Cake was recalled because egg allergen was not listed on the label, causing an allergic reaction in a consumer. The product was distributed to seven U.S. states.

    Product
    Highkey Soft Baked MINI TREATS BIRTHDAY CAKE NET WT 2 OZ (57g) CONTAINS: ALMONDS, MILD, AND COCONUT. DISTRIBUTED BY SUMMIT NATURALS INC ORLANDO, FL 32826 UPC 8 50020 43374 2
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-1447-2023·2023-05-24

    Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

    Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

    Product
    VentStar Anesthesia (N) 180, MP00333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2023·2023-05-24

    Anesthesia Ventilator Breathing Circuit Connections May Detach During Use

    Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.

    Product
    VentStar Anesthesia WT (P)180, MP00374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2023·2023-05-24

    Anesthesia Circuit Kit Coax 3 Connections May Detach During Ventilation

    Draeger Medical is recalling Anesthesia Circuit Kit Coax 3 units because glued connections can become loose or detach before or during ventilation. The recall covers 329,294 units distributed nationwide.

    Product
    Anesthesia Circuit Kit Coax 3, MP02732
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0884-2023·2023-05-24

    Highkey Banana Nut Muffin Mini Treats Recalled for Undeclared Egg Allergen

    Highkey soft baked MINI TREATS BANANA NUT MUFFIN are being recalled due to undeclared egg on the label. A consumer experienced an allergic reaction to the product.

    Product
    Highkey soft baked MINI TREATS BANANA NUT MUFFIN NET WT 2 OZ (57g) CONTAINS: ALMONDS, MILK, AND PECANS. DISTRIBUTED BY SUMMIT NATURALS INC ORLANDO, FL 32826 UPC 8 50020 43373 5
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0890-2023·2023-05-24

    Ground Cumin Distributed by Lipari Foods Recalled for Salmonella

    Lipari Foods is recalling 147 cases of ground cumin contaminated with Salmonella. The product was distributed to retail stores across 16 states.

    Product
    Distributed by Lipari Foods Ground Cumin in 6oz plastic tub, UPC 094776212620, 12 retail units per wholesale case
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1448-2023·2023-05-24

    VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment

    Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.

    Product
    VentStar Basic (N) 180, MP00353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0919-2023·2023-05-24

    Gold Medal Unbleached All Purpose Flour Recalled for Potential Salmonella Contamination

    General Mills is recalling Gold Medal Unbleached All Purpose Flour for potential Salmonella contamination. The recall affects 142,408 bags distributed nationwide with best-by dates of March 27–28, 2024.

    Product
    Gold Medal Unbleached All Purpose Flour, Enriched, Presifted, packaged in the following sizes: 1. Net Wt 5 lb (2.26kg), UPC 0 16000-19610 0; and 2. Net Wt 10 lb (4.53kg), UPC 0 16000-19580 6. Dist. By General Mills Sales, Inc., Minneapolid, MN 55440.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E040000·2023-05-24

    Veoneer Brake Booster Recall for Certain Honda Vehicles

    Veoneer is recalling brake booster assemblies in certain Honda vehicles because a tie rod fastener may be improperly assembled, risking brake failure.

    Product
    SERVICE BRAKES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2023·2023-05-24

    ID Circuit Basic breathing circuit recalled for loose glued connections

    Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    ID Circuit Basic (P) 180, MP01340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.

    Product
    ASM Replacement Battery, Component Number SUB0000864
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1451-2023·2023-05-24

    VentStar Coax breathing circuit connections recalled for detachment risk

    Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

    Product
    VentStar Coax (P) 150, MP00379
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0892-2023·2023-05-24

    Oregon Nut Blend Recalled for Undeclared Almonds and Cashews

    Willamette Hazelnut, Inc. is recalling Oregon Nut Blend because it contains undeclared almonds and cashews. This poses a risk to consumers allergic to these nuts.

    Product
    Oregon Nut Blend, Item # 5180808, Packed in cardboard box with poly liner; net wt. 25 lbs. No UPC. Label declares: Oregon Nut Blend, Innovative Bakery Resources. Ingredients: Hazelnuts, Walnuts. Product of USA. Manufactured By: Ardent Mills Tualatin, OR.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1440-2023·2023-05-24

    Draeger VentStar Basic ventilator breathing circuit connections may detach during use

    Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    VentStar Basic (P)180, MP00351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1449-2023·2023-05-24

    VentStar Watertrap breathing circuit connections may detach during ventilation

    Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.

    Product
    VentStar Watertrap (N) 180, MP00363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2023·2023-05-24

    Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

    ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

    Product
    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1457-2023·2023-05-24

    Ventstar Coax 230 breathing circuit connections can detach during ventilation

    The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

    Product
    Ventstar Coax 230, MP03376
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2023·2023-05-24

    Anesthesia circuit kit may detach during ventilation due to loose glued connections

    Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.

    Product
    Anesthesia Circuit Kit Coax HEPA, MP17102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2023·2023-05-24

    VentStar Breathing Bag Set Recalled for Loose Circuit Connections

    Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.

    Product
    VentStar breathing bag Set (P) 110, MP00384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1450-2023·2023-05-24

    Draeger VentStar Breathing Circuit Connections May Loosen During Use

    Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.

    Product
    VentStar Bag Set (N) 110, MP00383
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1441-2023·2023-05-24

    VentStar Basic ventilator breathing circuit connections may detach

    Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.

    Product
    VentStar Basic (P)250, MP00352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.

    Product
    ASM Replacement Battery, Component Number SUB0000594
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1442-2023·2023-05-24

    VentStar Watertrap Breathing Circuit Connections May Detach During Use

    Draeger Medical recalls VentStar Watertrap (P) 180 breathing circuit equipment because glued connections can become loose or detach before or during ventilation.

    Product
    VentStar Watertrap (P) 180, MP00361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1455-2023·2023-05-24

    Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach

    Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.

    Product
    Ventstar Coax 180, MP03374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0954-2023·2023-05-24

    Tahini Recall: Salmonella Contamination Risk in Mighty Sesame Organic Product

    Kenover Marketing Corp. is recalling Mighty Sesame Organic Tahini due to potential Salmonella contamination. The affected product was distributed to multiple states.

    Product
    Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) bottle, UPC 858313006208, 8 Units per case.
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1458-2023·2023-05-24

    Anesthesia Set Coax 180 Breathing Circuit Connection Risk

    Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.

    Product
    Anesthesia Set Coax 180, MP03384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1590-2023·2023-05-24

    Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate

    Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.

    Product
    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2023·2023-05-24

    Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

    ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1584-2023·2023-05-24

    Spectral CT X-Ray System Foot Switch May Entrap Operator's Foot

    The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.

    Product
    Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns

    Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2023·2023-05-24

    WATCHDOG Hemostasis Valve Kit recalled for insertion tool occlusion

    Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.

    Product
    WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1595-2023·2023-05-24

    Steris Reliance Vision Washer/Disinfector Recalled for Fire and Smoke Risk

    Steris is recalling 322 Reliance Vision Multi-Chamber Washer/Disinfectors because an electrical contactor malfunction could cause heating elements to overheat and produce smoke or fire.

    Product
    Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0894-2023·2023-05-24

    Trader Joe's Genova Pesto Recalled for Undisclosed Milk and Walnut Allergens

    Trader Joe's Genova Pesto is recalled due to labeling error: the product contains milk and walnuts but the label does not disclose these allergens. Affected product was distributed in Arizona, California, Florida, and Washington.

    Product
    Top Label: TRADER JOE'S GENOVA PESTO NET WT. 7 OZ. (198g) Side Label: TRADER JOE'S HUMMUS DIP NET WT. 7 OZ (98g) CONTAINS: SESAME. DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016 UPC 0015 7353
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0612-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0596-2023·2023-05-24

    Ampicillin and Sulbactam for Injection Recalled Due to Sterility Concerns

    Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0614-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2023·2023-05-24

    Philips Incisive CT System Foot Switch Pedal May Cause Foot Entrapment Injury

    Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.

    Product
    Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V365000·2023-05-24

    Loose Seat Belt Attachment in Winnebago and Itasca Motorhomes

    Winnebago and Itasca recall certain 2020-2023 motorhomes due to improperly tightened seat belt attachments that may fail to restrain occupants in a crash. Dealers will tighten fasteners free of charge.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA INSPIRE, ADVENTURER, VISTA, SHELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1605-2023·2023-05-24

    HydroPICC Catheter Kits Recalled for Expiration Date Mislabeling

    240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.

    Product
    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0886-2023·2023-05-24

    Dietary supplement Microbiome Rejuvenate recalled for glass fragment contamination

    Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.

    Product
    Microbiome Rejuvenate dietary supplement, 60 capsules per bottle, UPC: 8 50033 36201 5. Distributed by Big Bold Health, Bainbridge Island, WA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2023·2023-05-24

    YelloPort Elite Optical Trocars Recalled for Sterility Assurance Failure

    YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.

    Product
    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0607-2023·2023-05-24

    Cefepime for Injection recalled nationwide for lack of sterility assurance

    Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2023·2023-05-24

    Lorazepam injection vials recalled for elevated impurities and degradation

    Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0636-2023·2023-05-24

    Vancomycin injection recalled for lack of sterility assurance

    Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

    Product
    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1597-2023·2023-05-24

    Beckman Coulter Urine Analyzer Software Flag Display Issue Affects Carryover Detection

    Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.

    Product
    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0591-2023·2023-05-24

    Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns

    Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0615-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue

    Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2023·2023-05-24

    Ampicillin and Sulbactam for Injection recalled nationwide for sterility assurance deficiency

    Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0628-2023·2023-05-24

    Antibiotic Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2023·2023-05-24

    Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial

    Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.

    Product
    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns

    FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2023·2023-05-24

    Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2023·2023-05-24

    Vapor-Clean Anesthetic Filter Recalled Due to Manufacturing Leakage Defect

    Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.

    Product
    Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0638-2023·2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0613-2023·2023-05-24

    Ceftriaxone Injectable Recalled Due to Lack of Sterility Assurance

    Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.

    Product
    Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Failure

    Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0621-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0606-2023·2023-05-24

    Cefepime for Injection Recalled Due to Sterility Assurance Concerns

    The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
    Category
    Drug
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2023.