The Recall Desk

Archive

January 2025 recalls

560 recalls were announced in January 2025.

What the numbers show

Critical
13
Severe
109
High
391
Moderate
44
Low
3

Of the 560 recalls this month scored against our rubric, 2% are Critical, 19% are Severe.

101–200 of 560

  • SevereNHTSA·25V013000·2025-01-24

    Ducati Recalls 2025 Panigale V4 S for Rear Brake Hose Heat Damage

    Ducati is recalling 2025 Panigale V4 S motorcycles because excessive heat may damage the rear brake hose, causing sudden brake loss and increasing crash risk.

    Product
    DUCATI — DUCATI PANIGALE V4 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V034000·2025-01-24

    2025 Coachmen Catalina Travel Trailer Recall for Incorrect Weight Label

    Forest River is recalling 2025 Coachmen Catalina travel trailers because the Federal Placard lists an incorrect dry weight, which could lead to unintentional overloading.

    Product
    COACHMEN — COACHMEN CATALINA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V033000·2025-01-23

    Subaru Forester alloy wheels may be improperly attached losing stability

    Subaru is recalling certain 2025 Forester vehicles with 18-inch aluminium alloy wheels because an incorrectly specified lug seat surface can leave the wheel improperly attached.

    Product
    SUBARU — SUBARU FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V031000·2025-01-23

    Honda and Acura fuel injection software error can stall the engine

    Honda is recalling certain 2022-2025 Acura MDX Type-S, 2023-2025 Pilot and 2021-2025 Acura TLX Type-S vehicles because a fuel injection control unit software error may cause an engine stall or loss of power.

    Product
    ACURA — ACURA, HONDA MDX TYPE S, TLX TYPE S, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V032000·2025-01-23

    Acura MDX touchscreen can go blank hiding the rearview camera

    Honda is recalling certain 2025 Acura MDX vehicles because the centre console touchscreen may go blank, so the rearview camera image does not display. This fails FMVSS 111.

    Product
    ACURA — ACURA MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V030000·2025-01-23

    Mack Trucks Recalls MRU and Terrapro Towing Vehicles for Missing ABS

    Mack is recalling 2010-2025 MRU and Terrapro towing vehicles because they lack the anti-lock brake warning light and circuitry for attached trailers.

    Product
    MACK — MACK MRU, TERRAPRO (TE)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25102·2025-01-23

    Children's Holiday Pajama Sets recalled due to flammability violation

    Duluth Trading recalls about 22,400 children's holiday pajama sets that violate federal flammability regulations for sleepwear, posing a risk of burn injuries to children.

    Product
    Children's Holiday Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25103·2025-01-23

    NQDTPBOR Multi-Purpose Helmets Recalled Due to Head Injury Risk

    NQDTPBOR multi-purpose helmets for teens do not comply with federal bicycle safety standards for impact protection, stability, labeling, and certification. The recalled helmets, sold on Amazon from May to August 2024, can fail to protect wearers in a crash.

    Product
    NQDTPBOR Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25106·2025-01-23

    Teckwe Hair Dryer Brushes Recalled for Electrocution and Shock Hazard

    SHEIN Distribution is recalling about 310 Teckwe hair dryer brushes because they lack immersion protection, posing an electrocution or shock hazard if they fall into water while plugged in. No injuries have been reported.

    Product
    Teckwe Hair Dryer Brushes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0830-2025·2025-01-22

    Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.

    Product
    Impella RP Flex with SmartAssist; Product Number: 1000323;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0884-2025·2025-01-22

    Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability

    The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.

    Product
    Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0425-2025·2025-01-22

    Wicklow Gold Cheddar Nettle & Chive Cheese recalled for possible Listeria contamination

    Abbey Specialty Foods is recalling Wicklow Gold Cheddar Nettle & Chive Cheese due to possible Listeria monocytogenes contamination. The product was distributed to Massachusetts, Colorado, and Ohio.

    Product
    Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac , 8 packages per case
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0395-2025·2025-01-22

    Cucumber Spears Recalled Due to Potential Salmonella Contamination

    First Quality Produce is recalling Cucumber Spears in 5-lb trays due to potential Salmonella contamination. The recall affects distribution to 13 consignees in California.

    Product
    Cucumber Spear; 5-lb plastic trays Brand: First Quality Produce
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·003-2025·2025-01-22

    Custom Food Solutions Recalls Frozen Drunken Chicken for Undeclared Allergens

    Custom Food Solutions is recalling frozen drunken chicken due to undeclared egg and sesame allergens. No adverse reactions have been reported.

    Product
    Custom Food Solutions, LLC — Custom Food Solutions Recalls Ready-To-Eat Frozen Drunken Chicken Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0825-2025·2025-01-22

    ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk

    Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.

    Product
    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0887-2025·2025-01-22

    Life2000 Ventilation System battery charger defect causes device inoperability

    Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.

    Product
    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0389-2025·2025-01-22

    Boar's Head hummus vegetable platter recalled for Salmonella contamination

    Boar's Head hummus platters are recalled because they may contain cucumbers previously recalled for potential Salmonella contamination. Products were distributed across multiple states.

    Product
    BOAR'S HEAD HUMMUS VEG PLATTER SM, 2.5 lb., packaged in a plastic container with a plastic lid, UPC 42421-61545
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0886-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0388-2025·2025-01-22

    Small Veggie Platter Recalled for Potential Salmonella Contamination

    The Kroger Co is recalling Small Veggie Platters (32 oz) because they may contain cut cucumbers previously recalled due to potential Salmonella contamination.

    Product
    SMALL VEGGIE PLATTER, 32 oz., packaged in a plastic container with a plastic lid, UPC 41573-26809
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0824-2025·2025-01-22

    ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue

    Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.

    Product
    ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0426-2025·2025-01-22

    Wicklow Gold Cheddar Cheese Recalled for Potential Listeria Contamination

    Abbey Specialty Foods is recalling Wicklow Gold Cheddar Tomato & Herb cheese distributed in Massachusetts, Colorado, and Ohio due to potential Listeria monocytogenes contamination.

    Product
    Wicklow Gold Cheddar Tomato & Herb, 5.2 oz., plastic cryo-vac , 8 packages per case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0399-2025·2025-01-22

    Hardies Fresh Foods Cucumbers Recalled for Potential Salmonella Contamination

    Hardies Fresh Foods is recalling certain packaged cucumbers distributed in Texas for potential Salmonella contamination. Consumers should not consume affected products.

    Product
    14019 Cucumber Select 6 CT, 01034 Cucumber Select 5# packaged in polybags Dairyland Produce, LLC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0714-2025·2025-01-22

    Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup

    Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.

    Product
    Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0398-2025·2025-01-22

    Daily Veggies Enoki Mushroom Recalled for Possible Listeria Contamination

    New Age International recalls Daily Veggies Enoki Mushrooms due to potential Listeria monocytogenes contamination. The product was distributed in New York and Maryland; consumers should not consume it.

    Product
    Daily Veggies Enoki Mushroom, 200g Product of Korea UPC Codes: 8809159458890
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0826-2025·2025-01-22

    CRT-P Pacemakers Recalled for Potential Safety Mode Initiation Risk

    Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.

    Product
    VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0386-2025·2025-01-22

    Orgain Plant Protein Powder Recalled for Undeclared Peanut Allergen

    Orgain, LLC is recalling Orgain 30g Plant Protein powder (chocolate, lot #4172-02-P) due to potential contamination with undeclared peanuts. Consumers with peanut allergies should stop using the product.

    Product
    Orgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs, 1gSugar, Chocolate Flavor; NET WT 32.1 OZ (2.01 LB) 912g; Nutritional Facts: Serving size 2 scoops, UPC: 8 51770 00760 3; QUESTIONS ABOUT ORGAIN PRODUCTS? 888-881-GAIN(4246) Lot# 4172-02-P
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0822-2025·2025-01-22

    ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation

    Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.

    Product
    ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0823-2025·2025-01-22

    PROPONENT DR Pacemaker Recalled for Unexpected Safety Mode Risk

    Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.

    Product
    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2025·2025-01-22

    Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup

    Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.

    Product
    Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0402-2025·2025-01-22

    Pinsarella Roman Pizza Recalled for Undeclared Wheat and Soy Allergens

    Pinsarella Food LLC is recalling Roman Pizza products due to undeclared wheat and soy allergens. The affected products were distributed to restaurants in California through food distributors.

    Product
    Pinsarella Roman Pizza, POL127-24, UPC 6 08539 14655 0 -Oval, 12x7/ 7.0 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 1 98715 69442 0 - Oval, 14x9/ 10.6 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 6 08539 33371 4 - Round, 8" / 5.0 Oz, Parbaked, 6 units per bag…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0885-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability

    Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0393-2025·2025-01-22

    Snack Buddies Cucumber Coins Recalled Due to Potential Salmonella Contamination

    Snack Buddies Cucumber Coins are being recalled due to potential Salmonella contamination. The affected products were distributed exclusively to California food-service establishments, not retail stores.

    Product
    Cucumber Coins (sliced cucumbers); 1.25-oz, 2-oz, 2.16-oz, 2.25-oz, 2.6-oz, 3-oz, 4-oz Brand: Snack Buddies
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0200-2025·2025-01-22

    Systane Lubricant Eye Drops Recalled for Non-Sterility Risk

    Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.

    Product
    Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0764-2025·2025-01-22

    Medline Fluid Delivery Sets incorrectly assembled with wrong drip chamber

    Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.

    Product
    Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2025·2025-01-22

    Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation

    Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.

    Product
    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0394-2025·2025-01-22

    First Quality Produce Cucumber Coins Recalled for Salmonella Contamination Risk

    First Quality Produce is recalling Cucumber Coins (sliced cucumbers in 5-lb trays) due to potential Salmonella contamination. The product was distributed to food service operators in California.

    Product
    Cucumber Coins (sliced cucumbers); 5-lb plastic trays Brand: First Quality Produce
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0387-2025·2025-01-22

    Kroger Deli Fresh Vegetable Tray Recalled for Potential Salmonella

    The Kroger Co is recalling Deli Fresh Vegetable Trays that may contain previously recalled cucumbers with potential Salmonella contamination.

    Product
    DELI FRESH VEGETABLE TRAY MED, 4 lb., packaged in a plastic container with a plastic lid, UPC 11110-99274
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0827-2025·2025-01-22

    VISIONIST CRT-P Pacemakers Recalled Due to Battery Impedance Risk

    Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.

    Product
    VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0400-2025·2025-01-22

    Cucumbers sold in multiple states recalled due to Salmonella contamination risk

    Wholesale Produce Supply is recalling cucumbers sold in multiple Midwest states and Canada due to potential Salmonella contamination. Consumers should not eat the affected product and should dispose of it safely.

    Product
    Cucumbers, Wholesale Produce Supply, 752 Kasota Circle, Minneapolis, MN 554145. Product of Mexico. Cucumbers sold in the following pack sizes: 1. 5 lb. pack 2. 6 ct individual items per case. 3. 12 ct individual items per case. 4. 24 ct individual items per case. 5.…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0713-2025·2025-01-22

    Endoscopic Access Overtube May Cause Dangerous Pressure Buildup During Procedures

    Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.

    Product
    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0829-2025·2025-01-22

    Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.

    Product
    Impella RP with SmartAssist; Product Number: 0046-0035;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2025·2025-01-22

    Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk

    Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.

    Product
    Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0905-2025·2025-01-22

    Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing

    Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.

    Product
    Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0396-2025·2025-01-22

    Diced Cucumber from First Quality Produce Recalled for Salmonella

    First Quality Produce is recalling diced cucumber (5-lb trays) due to potential Salmonella contamination. The recalled product was distributed to consignees in California and was not sold at retail.

    Product
    Cucumber Diced; 5-lb plastic trays Brand: First Quality Produce
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0765-2025·2025-01-22

    Medline Fluid Delivery Sets Recalled Due to Assembly Error

    Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.

    Product
    Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0390-2025·2025-01-22

    Boar's Head Hummus Vegetable Platter recalled for potential Salmonella

    Boar's Head Hummus Vegetable Platter 5 lb. packages may contain cut cucumbers contaminated with Salmonella. The recall affects 121 units distributed in AZ, CO, LA, NM, TX, UT, and WY.

    Product
    BOAR'S HEAD HUMMUS VEG PLATTER MED, 5 lb., packaged in a plastic container with a plastic lid, UPC 42421-61547
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0831-2025·2025-01-22

    Dialysis Blood Circuit May Cause Excessive Fluid Removal

    The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.

    Product
    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2025·2025-01-22

    Orthopedic Surgery Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG orthopedic surgery kits due to packaging defects that may compromise sterility. The affected kits (Model 96-4780A, Lot HSI) were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2025·2025-01-22

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.

    Product
    Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2025·2025-01-22

    Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk

    GE Healthcare's Infinia nuclear medicine systems may have been transported without proper detector support, risking detector falls and life-threatening injury. The recall affects 93 units worldwide.

    Product
    GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0954-2025·2025-01-22

    Surgical instrument kits recalled for potential sterile packaging defects

    Sklar Instruments is recalling 41,850 units of ECONO STERILE surgical procedure kits due to packaging defects that may compromise the sterile barrier, affecting multiple clamp and hemostat models used in general orthopedic surgery.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2025·2025-01-22

    ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk

    Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Surgical Scalpel Handles for Sterile Barrier Risk

    Sklar Instruments recalls ECONO STERILE SCALPEL HDL #3 surgical handles due to packaging issues that may compromise the sterile barrier. The 150-unit recall affects units distributed nationwide with lot code SK-125.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0842-2025·2025-01-22

    Augustine Temperature Management Controller Experiences Power-On Self-Test Failures

    Augustine's HOT DOG temperature management controller (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code 'EA POST' that indicates a diagnostic failure. Approximately 2,271 units have been distributed worldwide.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0930-2025·2025-01-22

    Medical procedure kit recall due to sterile barrier packaging breach risk

    Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2025·2025-01-22

    Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk

    Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.

    Product
    Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2025·2025-01-22

    Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference

    QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2025·2025-01-22

    Intuitive Surgical 8mm Cadiere Forceps Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.

    Product
    8MM,CADIERE FORCEPS,IS4000 REF 471049
    Category
    Medical Device
    Distribution
    52 states
  • HighNHTSA·25V027000·2025-01-22

    Starcraft Bus Recalls 2023-2024 Models for Emergency Exit Handle Issues

    Forest River is recalling 2023-2024 Starcraft Starlite and Allstar buses because emergency exit handles are not easily accessible, potentially delaying passenger evacuation.

    Product
    STARCRAFT BUS — STARCRAFT BUS STARLITE, ALLSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2025·2025-01-22

    Medical Procedure Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2025·2025-01-22

    GE Healthcare nuclear medicine systems recalled for detector support risk

    GE Healthcare nuclear medicine systems including Infinia II Hawkeye 4 may have been transported without proper detector support, risking detector failure and serious injury.

    Product
    GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0939-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Medical Procedure Kits for Sterile Barrier Breach Risk

    Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled for Frayed Grip Cable

    Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0951-2025·2025-01-22

    Sklar Instruments iris hooks recalled for sterile packaging integrity issues

    Sklar Instruments is recalling ECONO STERILE iris hook surgical kits due to packaging defects that may compromise sterile barrier integrity. No injuries reported.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk

    GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.

    Product
    GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0861-2025·2025-01-22

    HEM-O-LOK Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier for frayed or broken grip cables on the reusable surgical instrument jaws.

    Product
    8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0935-2025·2025-01-22

    Sklar Instruments Recalls Sterile Vein Hooks Due to Packaging Issues

    Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2025·2025-01-22

    ProGrasp Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical recalls ProGrasp Forceps instruments due to increased complaints of frayed or broken grip cables. Approximately 99,249 units distributed in the U.S. and internationally are affected.

    Product
    8MM,PROGRASP FORCEPS,IS4000 REF 471093
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0912-2025·2025-01-22

    Cardinal Health Laryngoscopy Presource Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling 512,786 Laryngoscopy Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the United States, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2025·2025-01-22

    Murata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms

    The muRata Vios Monitoring System Model 2050 central station monitor can display distorted and flickering ECG waveforms and vital signs. The issue affects only the central station display, not the bedside monitor or patient monitoring accuracy.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2025·2025-01-22

    Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2025·2025-01-22

    ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues

    Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2025·2025-01-22

    ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues

    Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2025·2025-01-22

    Cardinal Health Presource Aneurysm Packs recalled for potential endotoxin contamination

    Cardinal Health Presource surgical kits used in aneurysm procedures may contain endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units distributed worldwide; no illnesses reported.

    Product
    Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2025·2025-01-22

    ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues

    Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2025·2025-01-22

    Intuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects

    Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0860-2025·2025-01-22

    Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.

    Product
    8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0881-2025·2025-01-22

    Intuitive Surgical Bipolar Dissector Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0891-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk

    GE Healthcare is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.

    Product
    GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0883-2025·2025-01-22

    Intuitive Surgical recalls 8MM Force Bipolar surgical instruments due to grip cable failures

    Intuitive Surgical is recalling approximately 46,759 8MM Force Bipolar IS4000 surgical instruments nationwide and internationally due to reports of frayed or broken grip cables that could compromise instrument function during surgical use.

    Product
    8MM,FORCE BIPOLAR,IS4000 REF 471405
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0950-2025·2025-01-22

    Strabismus Surgical Scissors Kits Recalled Due to Sterile Barrier Packaging Issues

    Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.

    Product
    Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2025·2025-01-22

    Intuitive Surgical Clip Applier Instruments Recalled for Frayed or Broken Cables

    Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0948-2025·2025-01-22

    Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues

    Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2025·2025-01-22

    Surgical Suction Tubes Recalled for Sterile Packaging Defects

    ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0203-2025·2025-01-22

    Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

    Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2025·2025-01-22

    VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance

    Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.

    Product
    VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2025·2025-01-22

    Surgical Kit Recall: Potential Endotoxin Contamination in Cardinal Health Presource Kits

    Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2025·2025-01-22

    Idylla diagnostic INSTRUMENT recalled due to false-positive MSI-H test results

    The Biocartis Idylla INSTRUMENT, an in vitro diagnostic device, has been recalled due to false-positive results in MSI-H testing. These false-positive results could lead to inaccurate diagnoses.

    Product
    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0839-2025·2025-01-22

    Augustine Surgical temperature management controllers may experience power-on self-test error

    Augustine Surgical temperature management controllers (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code. Seventeen units have been recalled worldwide.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0927-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2025·2025-01-22

    ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.

    Product
    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2025·2025-01-22

    GE Healthcare nuclear medicine imaging systems recalled for detector fall risk

    GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.

    Product
    GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0904-2025·2025-01-22

    Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation

    Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.

    Product
    Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2025·2025-01-22

    ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues

    Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.

    Product
    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
    Category
    Medical Device
    Distribution
    Distributed nationwide

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