The Recall Desk

Archive

October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical
4
Severe
86
High
449
Moderate
62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

101–200 of 601

  • HighFDA (Devices)·Z-0149-2025·2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2025·2024-10-30

    Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen

    AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.

    Product
    AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2025·2024-10-30

    Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled

    Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.

    Product
    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk

    Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards

    Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.

    Product
    Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0167-2025·2024-10-30

    Medline chest tube insertion tray may contain non-sterile equipment due to breached seal

    Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.

    Product
    Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2025·2024-10-30

    Smiths Medical Arterial Kit recalled for pressure monitoring defect

    Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.

    Product
    medex Arterial Kit 1/EA, Product Code REF MX7827
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0205-2025·2024-10-30

    Smiths Medical SurgiVet pressure transducer recalled for monitoring failures

    Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.

    Product
    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0193-2025·2024-10-30

    Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect

    Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.

    Product
    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0213-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 recalled for electrical hazard

    Baxter is recalling 1,077 TruSystem 7000 operating tables worldwide due to electrical short-circuits and smoke emissions in battery connectors reported by customers.

    Product
    Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0012-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0217-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 U14 Recalled for Battery Short-Circuit Risk

    Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.

    Product
    Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2025·2024-10-30

    Medex TranStar pressure monitoring sets recalled due to manufacturing defect

    Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.

    Product
    medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0172-2025·2024-10-30

    Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised

    Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.

    Product
    Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2025·2024-10-30

    Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk

    Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.

    Product
    Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2025·2024-10-30

    ENT Medication Reservoirs Recalled for Weakened Weld Joint

    Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.

    Product
    ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0156-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging

    Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2025·2024-10-30

    Medex TranStar Kids Blood Sample Kit Pressure Monitoring Defect Recall

    Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.

    Product
    medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0163-2025·2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2025·2024-10-30

    Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues

    Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.

    Product
    smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0162-2025·2024-10-30

    Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging

    Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.

    Product
    Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk

    Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.

    Product
    Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0219-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error

    Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2025·2024-10-30

    Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error

    Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.

    Product
    Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error

    Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2025·2024-10-30

    Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk

    Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2025·2024-10-30

    Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects

    Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.

    Product
    medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0195-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled Due to Manufacturing Defect

    Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.

    Product
    medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0150-2025·2024-10-30

    Medline Centurion Medical Procedure Kits Recalled for Sterility Risk

    Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.

    Product
    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2025·2024-10-30

    Smiths Medical medex TranStar Pressure Monitoring Kits Recalled for Manufacturing Defect

    Smiths Medical is recalling 5,880 medex TranStar pressure monitoring kits worldwide due to a manufacturing defect that may cause inaccurate readings, monitoring interruption, or inability to zero the device.

    Product
    medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0133-2025·2024-10-30

    Medline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects

    Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.

    Product
    (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring

    Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.

    Product
    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0152-2025·2024-10-30

    Medline CV Anesthesia Room Setup Kits Recalled for Sterility Risk

    Medline is recalling 15 CV Anesthesia Room Setup kits because a packaging defect may allow non-sterile product use if the pouch seal is opened.

    Product
    Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2025·2024-10-30

    Medline medical procedure kits recalled for potential sterility breach

    Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2025·2024-10-30

    CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects

    Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.

    Product
    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0212-2025·2024-10-30

    Baxter Operating Table Recalled for Battery Short-Circuit and Smoke Risk

    Baxter is recalling its TruSystem 7000 operating table worldwide due to customer reports of battery and connector short-circuits that emitted smoke. All serial numbers are affected.

    Product
    Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0166-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Class II Recall

    Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2025·2024-10-30

    Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming

    Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.

    Product
    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0138-2025·2024-10-30

    Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.

    Product
    Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2025·2024-10-30

    Drug injection product recalled due to manufacturing quality violations

    Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0018-2025·2024-10-30

    Vancomycin Injection Recalled Due to Manufacturing Process Violations

    Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.

    Product
    Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2025·2024-10-30

    Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0021-2025·2024-10-30

    Oxytocin Injection Recalled for Current Good Manufacturing Practice Violations

    Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.

    Product
    Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2025·2024-10-30

    Sterile drug injection bags recalled for manufacturing process violations

    Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0207-2025·2024-10-30

    Diasol Acid Concentrate Recalled for Labeling Discrepancy

    Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.

    Product
    Diasol Acid Concentrate REF G100325-10Dex 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0064-2025·2024-10-30

    Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage

    Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.

    Product
    Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0209-2025·2024-10-30

    Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance

    Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.

    Product
    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2025·2024-10-30

    Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations

    Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.

    Product
    OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2025·2024-10-30

    Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns

    Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.

    Product
    smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
    Category
    Medical Device
    Distribution
    0 states
  • SevereUSDA FSIS·029-2024·2024-10-29

    A Tu Gusto Recalls Frozen Croquettes for Undeclared Allergens and Lack of Inspection

    A Tu Gusto, LLC is recalling approximately 7,630 pounds of frozen croquette products that were produced without federal inspection and contain undeclared allergens.

    Product
    A Tu Gusto, LLC Recalls Frozen Croquette Products Produced Without the Benefit of Inspection and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·24V811000·2024-10-29

    Gillig Recalls 2024 Low Floor Buses Due to Wiper Arm Defect

    Gillig is recalling 2024 Low Floor buses because a defective welded joint may cause the wiper arm to fail, reducing visibility and increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E091000·2024-10-29

    Chrysler Recalls Air Bag Control Modules Due to Excessive Deployment Force

    Chrysler is recalling Mopar Sophisticated Air Bag Sensor modules because a software error may cause front air bags to deploy with excessive force, increasing injury risk.

    Product
    AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V809000·2024-10-28

    Porsche Recalls 2021-2024 Models for Wheel Bolt Fracture Risk

    Porsche is recalling 2,251 vehicles because a center lock wheel bolt may fracture, causing the wheel to detach and increasing crash risk.

    Product
    PORSCHE — PORSCHE 718 SPYDER RS, 718 CAYMAN GT4 RS, 911
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V805000·2024-10-25

    Ford Recalls 2023-2024 Transit Vehicles for Rear Axle Bolt Defect

    Ford is recalling 2023-2024 Transit vehicles previously repaired under recall 24V-102 because incorrect rear axle shaft bolts may cause wheel lock-up or separation.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V806000·2024-10-25

    Ford Super Duty tailgate camera modules may admit water

    Ford is recalling certain 2023-2024 F-250, F-350 and F-450 vehicles because water may enter the tailgate park assist module and disrupt the rearview camera image.

    Product
    FORD — FORD F-450 SD, F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V803000·2024-10-25

    Palomino axle equalizer may contact and damage the LP gas manifold

    Forest River is recalling certain 2025 Palomino recreational vehicles because the axle equalizer may contact and damage the LP gas manifold, causing a propane leak.

    Product
    FOREST RIVER — FOREST RIVER PALOMINO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V801000·2024-10-25

    Ford Explorer rearview camera image may fail above ten miles per hour

    Ford is recalling certain 2025 Explorer and Lincoln Aviator vehicles because the rearview camera image may fail when vehicle speed reaches 10 mph or more.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V797000·2024-10-24

    GM diesel transmission control valves may fail and lock rear wheels

    GM is recalling certain 2020-2022 diesel Silverado, Sierra, Escalade, Tahoe, Suburban and Yukon vehicles because the transmission control valve may fail and cause rear wheel lock-up.

    Product
    CHEVROLET — CHEVROLET, GMC, CADILLAC TAHOE, SIERRA 3500, SILVERADO 2500, YUKON XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V796000·2024-10-24

    Inspire Recalls 2024 Newport Trailers Due to Cooktop Fire Risk

    Inspire RVs is recalling 2024 Newport 27 and 29 trailers because a cooktop circuit board may overheat and cause a fire. All affected units were repaired in September 2024.

    Product
    INSPIRE — INSPIRE NEWPORT 29, NEWPORT 27
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E090000·2024-10-24

    Reading Truck Equipment Recalls Curt Trailer Hitches on Ford Trucks

    Reading Truck Equipment is recalling 116 Curt trailer hitches installed on 2023-2024 Ford F350 and F550 vehicles because fuel tank straps were not properly tightened.

    Product
    FUEL SYSTEM, DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25021·2024-10-24

    Ricky Powersports ATVs Recalled for Safety Regulation Violations

    Ricky Powersports is recalling about 385 youth and adult all-terrain vehicles due to violations of federal ATV safety regulations that pose risks of serious injury or death. The youth ATVs have suspension defects, and the adult ATVs have brake and handlebar safety issues.

    Product
    Ricky Powersports Tumble Weed Youth and TGB Blade Adult All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10242024-01·2024-10-24

    USDA Issues Public Health Alert for Illegally Imported Myanmar Meat and Poultry

    USDA FSIS issued a public health alert for seven types of meat and poultry products illegally imported from Myanmar. Consumers are urged not to consume these products.

    Product
    FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from the Republic of the Union of Myanmar
    Category
    Food
    Distribution
    9 states
  • HighCPSC·25019·2024-10-24

    CFMOTO 2024 CFORCE All-Terrain Vehicles Recalled for Throttle Failure Crash Hazard

    CFMOTO is recalling about 2,650 of its 2024 CFORCE 800 Touring and 2024 CFORCE 1000 Touring ATVs because the throttle lever can fail to return to idle, causing unexpected acceleration and crash risk. One minor injury has been reported.

    Product
    2024 CFORCE 800 Touring and 2024 CFORCE 1000 Touring All-Terrain Vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V799000·2024-10-24

    Spartan Fire Recalls Fire Trucks Due to Cab Tilt Cylinder Defect

    Spartan Fire is recalling 2024-2025 fire trucks because a missing mechanical stop may allow the cab tilt cylinder to overextend, potentially causing the cab to drop.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME FC-94, PANTHER, METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V798000·2024-10-24

    Nissan Z pedestrian sensor connectors may be reversed in the harness

    Nissan is recalling certain 2023-2024 Z vehicles because right-side pedestrian detection sensor connectors may be reversed, preventing the pop-up engine hood from activating.

    Product
    NISSAN — NISSAN Z
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V793000·2024-10-24

    Chrysler Pacifica side curtain airbag connectors may be improperly secured

    Chrysler is recalling certain 2020-2023 Pacifica and Voyager vehicles because an improperly secured side curtain airbag connector may prevent the airbags from deploying.

    Product
    CHRYSLER — CHRYSLER PACIFICA, VOYAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V800000·2024-10-24

    Orange EV Recalls T-Series and e-TRIEVER Trucks for Manual Errors

    Orange EV is recalling 2017-2024 T-Series and 2023-2024 e-TRIEVER trucks because manuals incorrectly describe the high-voltage lockout procedure, posing an electrical shock risk.

    Product
    ORANGE EV — ORANGE EV T-SERIES ELECTRIC TRUCK, E-TRIEVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·25020·2024-10-24

    PowerBlock Commercial Pro 100 Weight Sets with 5 lb Grip Handles Recalled

    PowerBlock is recalling about 1,845 Commercial Pro 100 weight sets sold with 5 lb grip handles because weight plates above 55 lbs can dislodge during use, posing an impact injury risk.

    Product
    Commercial Pro 100 sold with 5 lb grip handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0036-2025·2024-10-23

    Enjoy Premium Coconut Cookies Recalled for Undeclared Milk Allergen

    KTM Services, Inc. is recalling Enjoy Premium Coconut Cookies sold in Hawaii, Guam, Nevada, and online due to undeclared milk allergen. Consumers with milk allergies should not consume the product.

    Product
    Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0048-2025·2024-10-23

    GE HealthCare Recalls Giraffe OmniBed Carestations Due to Door Screw Issue

    GE HealthCare is recalling certain Giraffe OmniBed Carestations because a screw securing the heater doors may not be torqued to specification, potentially causing the doors to become loose.

    Product
    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0035-2025·2024-10-23

    Enjoy Premium Taro Cookies recalled for undeclared milk allergen

    Enjoy Premium Taro Cookies contain undeclared milk allergen and were sold in Hawaii, Guam, and Nevada. Consumers with milk allergies should not consume this product.

    Product
    Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0044-2025·2024-10-23

    Seasoned Dandelion Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD1070A Seasoned Dandelion due to undeclared fish (anchovy) not listed on the label. Consumers with fish allergies should not consume this product.

    Product
    Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, Salt, Garlic, Soy Sauce, Chili Powder.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0037-2025·2024-10-23

    Nuts.com recalls S'mores Bites for undeclared milk allergen

    Nuts.com is recalling S'mores Bites due to undeclared milk allergen. Milk chocolate was listed in the product description but omitted from the ingredient list, creating a labeling mismatch.

    Product
    S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016
    Category
    Food
    Distribution
    36 states
  • SevereNHTSA·24E089000·2024-10-23

    Silver Eagle Recalls Eye and Shank Assemblies Due to Weld Fatigue

    Silver Eagle is recalling specific eye and shank assemblies because welds may crack, allowing the eye to separate from the trailer converter dolly and increasing crash risk.

    Product
    STRUCTURE:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0043-2025·2024-10-23

    Seasoned Radish Recalled for Undeclared Crustacean Allergen

    Lemonland Food Corp is recalling Item FLD1080A Seasoned Radish due to undeclared shrimp. The product was distributed in Washington; consumers with crustacean allergies should not consume it.

    Product
    Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pepper Powder, Malt Syrup, Salt, Anchovy, Sugar, Garlic, Ginger, Sesame.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0046-2025·2024-10-23

    Octopus Product Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Item FLD2011 Salted and Seasoned Small Octopus because it contains undeclared fish (anchovy), a major allergen. Approximately 70 packages were distributed in Washington state.

    Product
    Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares: Octopus, Salt, Garlic, Ginger, Red Pepper Powder, Green Onion, Syrup, Sesame Seed.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0038-2025·2024-10-23

    Potato Salad Recall: Undeclared Egg and Soybean Allergens

    Lemonland Food Corp is recalling potato salad due to undeclared egg and soybean allergens present in the mayonnaise ingredient. The recall affects 120 packages distributed in Washington.

    Product
    Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0041-2025·2024-10-23

    Perilla Leaves in Soy Sauce recalled for undeclared wheat and fish allergens

    Lemonland Food Corp recalls Item FLD1000BA Perilla Leaves in Soy Sauce due to undeclared wheat and fish allergens on the label. Consumers with these allergies should not consume the product.

    Product
    Item FLD1000BA, Perilla Leaves in Soy Sauce, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Perilla Leaves, Soy Sauce, Sugar
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0048-2025·2024-10-23

    Seasoned Pepper with Soybean Paste Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Item FLD1020A Seasoned Pepper with Soybean Paste due to undeclared wheat, fish, and crustacean allergens. Consumers with allergies should not consume this product.

    Product
    Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Pepper, Soy Bean Paste.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0012-2025·2024-10-23

    Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination

    Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.

    Product
    ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0047-2025·2024-10-23

    GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen

    Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.

    Product
    GE Heathcare Giraffe OmniBed; neo natal incubator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0049-2025·2024-10-23

    KINOVA Jaco assistive robot recalled for potential fire hazard

    Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.

    Product
    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2025·2024-10-23

    BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk

    BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.

    Product
    BlueFIRE Inflation Device, REF: IN10140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2025·2024-10-23

    Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays

    Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.

    Product
    Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2025·2024-10-23

    Duloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity

    Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk

    Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V790000·2024-10-23

    Volvo trucks with Bendix EC80 units may lose safety system functions

    Volvo Trucks is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.

    Product
    VOLVO — VOLVO VAH, VHD, VN, VNRE (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V792000·2024-10-23

    Mack trucks with Bendix EC80 units may lose safety system functions

    Mack is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.

    Product
    MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), GRANITE (GR), PIONEER PR (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2025·2024-10-23

    AVVIGO+ Medical Imaging System Grid Overlay Display Software Error

    Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
    Category
    Medical Device
    Distribution
    Distributed nationwide

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