The Recall Desk

Archive

November 2024 recalls

510 recalls were announced in November 2024.

What the numbers show

Critical
11
Severe
101
High
348
Moderate
39
Low
11

Of the 510 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

101–200 of 510

  • SevereNHTSA·24V880000·2024-11-21

    International Recalls 2022-2025 HX Trucks for Brake Release Delay

    International is recalling 2022-2025 HX trucks because the service brake may take longer than expected to release, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V878000·2024-11-21

    Toyota Corolla steering intermediate shafts may fracture and detach

    Toyota is recalling certain 2023-2024 Corolla and Corolla Hybrid vehicles because manufacturing cracks may cause the steering intermediate shaft to fracture and detach.

    Product
    TOYOTA — TOYOTA COROLLA, COROLLA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25051·2024-11-21

    Nerf Barrage Youth Bicycle Helmets Recalled for Head Injury Risk

    About 6,500 Nerf Barrage youth helmets sold at Walmart (2022–2024) are recalled for retention system failures violating federal safety standards. No injuries reported. Consumers should stop using the helmets and contact Todson for a refund.

    Product
    Nerf Barrage Youth Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25054·2024-11-21

    South Shore cribs recalled for entrapment hazard in slat spacing

    South Shore cribs sold from July 2020 to February 2024 have wider-than-standard slat spacing, creating an entrapment hazard for children. The company is offering full refunds and consumers should stop using the recalled cribs immediately.

    Product
    South Shore Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V882000·2024-11-21

    Honda Africa Twin fuel injection software may stall the engine

    Honda is recalling certain 2022 and 2024-2025 CRF1100 Africa Twin motorcycles because an FI-ECU software error may cause an engine stall or loss of power with Wheelie Control active.

    Product
    HONDA — HONDA CRF1100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V879000·2024-11-21

    Hyundai Elantra and Santa Fe rearview cameras have damaged circuit boards

    Hyundai is recalling certain 2021-2022 Santa Fe and Elantra vehicles because a damaged printed circuit board may cause the rearview camera image to fail. 226,118 units affected.

    Product
    HYUNDAI — HYUNDAI SANTA FE HYBRID, ELANTRA N, SANTA FE PLUG-IN HYBRID, SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·031-2024·2024-11-20

    Wolverine Packing Recalls Ground Beef Due to E. Coli O157:H7 Contamination

    Wolverine Packing Co. is recalling approximately 167,277 pounds of ground beef products due to possible E. coli O157:H7 contamination linked to an illness cluster in Minnesota.

    Product
    Wolverine Packing Co. — Wolverine Packing Co. Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0310-2025·2024-11-20

    Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors

    Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.

    Product
    Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0304-2025·2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0303-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.

    Product
    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0135-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling 42 cases of raw yellow onions in 5-lb bags distributed to food service facilities across six states due to potential E. coli O157:H7 contamination.

    Product
    raw, yellow onions (whole unpeeled), intended for food service, repacked into in 5-lb plastic bags
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0305-2025·2024-11-20

    Anesthesia workstation piston ventilator may fail before or during use

    Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0406-2025·2024-11-20

    AVID Medical Recalls Halyard C Section Bundles Due to Metal Flakes

    AVID Medical, Inc. is recalling Halyard C Section Bundles because small metal flakes may detach from sponge forceps and towel clamps, posing a risk of foreign body reactions.

    Product
    Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0404-2025·2024-11-20

    AVID Medical Recalls Halyard Laparoscopy Trays Due to Metal Flakes

    AVID Medical is recalling 42 Halyard Laparoscopy Trays because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0357-2025·2024-11-20

    Medline Recalls Non-Sterile Urinalysis Kit Specimen Containers

    Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or hospitalization.

    Product
    URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E098000·2024-11-20

    Lippert Recalls Fifth Wheel Pin Boxes Due to Fastener Issues

    Lippert is recalling specific Curt Helux Pin Boxes installed in Lippert 5W Chassis because fasteners may be improperly tightened, increasing crash risk.

    Product
    TRAILER HITCHES:FIFTH WHEEL ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2025·2024-11-20

    Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk

    Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0136-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling raw yellow onions due to potential E. coli O157:H7 contamination distributed to food service facilities in CO, KS, MO, NE, NM, and UT.

    Product
    raw, yellow onions (whole unpeeled), intended for food service, in 50-lb corrugated boxes
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·24E099000·2024-11-20

    Agility Fuel Solutions Recalls CNG Fuel Systems Due to Valve Cracks

    Agility Fuel Solutions is recalling certain CNG fuel systems because manual cylinder valves may develop stress corrosion cracks, causing a natural gas leak that increases fire risk.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0299-2025·2024-11-20

    Cryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0296-2025·2024-11-20

    Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure

    Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.

    Product
    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0294-2025·2024-11-20

    Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols

    Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.

    Product
    Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V877000·2024-11-20

    Hyundai Tucson console wiring may allow shifting out of Park unbraked

    Hyundai is recalling certain 2025 Tucson and Santa Cruz vehicles because misrouted console wiring may allow the transmission to shift out of Park without the brake applied.

    Product
    HYUNDAI — HYUNDAI SANTA CRUZ, TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0298-2025·2024-11-20

    FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0297-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0290-2025·2024-11-20

    Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction

    Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.

    Product
    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0302-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0301-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk

    Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0312-2025·2024-11-20

    FHC microTargeting Insertion Tube Set Recalled for Spacer Defect

    FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.

    Product
    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·F-0137-2025·2024-11-20

    Yellow Onion Products Recalled for E. Coli O157:H7 Contamination

    IMPERIALFRESH processed yellow onions are being recalled due to potential E. coli O157:H7 contamination. Products were distributed in Colorado and produced October 8-22, 2024.

    Product
    Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147 4/5LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 1/4 All lot codes; 259369 1 / 5
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0134-2025·2024-11-20

    Raw Yellow Onions Recalled for Potential E. coli O157:H7 Contamination

    Taylor Farms Colorado is recalling 615 cases of raw yellow onions for potential E. coli O157:H7 contamination. Affected food service facilities are in CO, KS, MO, NE, NM, and UT.

    Product
    raw, yellow onions (whole peeled), intended for food service, packaged into plastic bags (5-lbs)
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0133-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling raw yellow onions distributed to food service facilities in six states due to potential E. coli O157:H7 contamination. Use-through dates range from October 16 to November 3, 2024.

    Product
    raw, yellow onions (sliced, diced, slivered, ringed), intended for food service, packaged in plastic bags
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0138-2025·2024-11-20

    Processed Fajita Peppers Recalled for Potential E. coli O157:H7 Contamination

    ImperialFresh processed fajita peppers made by FreshPoint Denver, Incorporated have been recalled due to potential E. coli O157:H7 contamination. Seven cases distributed in Colorado are affected.

    Product
    154784 1 / 5LB IMPERIALFRESH PROC FAJITA GRN PEPRED PEP W All lot codes
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0291-2025·2024-11-20

    Philips Trilogy Evo ventilators recall: flow sensor fouling risk

    Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.

    Product
    Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0292-2025·2024-11-20

    Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk

    Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.

    Product
    Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2025·2024-11-20

    AVID Medical Recalls Halyard Line Insertion Packs Due to Metal Flakes

    AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2025·2024-11-20

    AVID Medical Recalls Halyard CPT PEDS ADULT CH PACK Surgical Kits

    AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.

    Product
    Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2025·2024-11-20

    AVID Medical Recalls Halyard MINOR PDS Medical Convenience Kits

    AVID Medical, Inc. is recalling 137 Halyard MINOR PDS medical convenience kits because sponge forceps and towel clamps may release metal flakes into surgical sites.

    Product
    Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V875000·2024-11-20

    Volkswagen ID.4 rearview camera image may not display in reverse

    Volkswagen is recalling certain 2023 ID.4 vehicles because the rearview camera image may not display when the vehicle is placed in reverse, failing FMVSS 111.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2025·2024-11-20

    AVID Medical Recalls Pacemaker Convenience Kits Due to Metal Flakes

    AVID Medical, Inc. is recalling Halyard SAMMC-N pacemaker convenience kits because sponge forceps and towel clamps may shed metal flakes that could enter a patient's surgical site.

    Product
    Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2025·2024-11-20

    Metrix SECURE 1000 mL IV Container Recall Due to Leaking

    The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.

    Product
    SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V876000·2024-11-20

    Oliver travel trailer water heater burner brackets may loosen and misdirect flame

    Oliver Travel Trailers is recalling certain 2016-2024 Elite I and Elite II trailers because the Truma water heater burner bracket may loosen, misdirecting the flame.

    Product
    OLIVER TRAVEL TRAILERS — OLIVER TRAVEL TRAILERS LEGACY ELITE, LEGACY ELITE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2025·2024-11-20

    AVID Medical Recalls Heart Cath Lab Kits Due to Metal Flakes

    AVID Medical is recalling 411 Heart Cath Lab Kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2025·2024-11-20

    Medtronic Recharger Kits Recalled for Potential Failure to Initiate Recharging

    Medtronic is recalling 118 wireless recharger kits for implantable neurostimulators because they may fail to start a recharging session upon first use.

    Product
    Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Bra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2025·2024-11-20

    AVID Medical Recalls Halyard EP PACK Kits Due to Metal Flakes

    AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard EP PACK - Medical convenience kits Model Number: VANW018-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2025·2024-11-20

    AVID Medical Recalls Halyard Surgical Kits Due to Metal Flakes

    AVID Medical is recalling Halyard SPECIALS PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2025·2024-11-20

    Halyard CPT Cardiac Cath Pack Recalled Due to Loose Metal Flakes in Forceps and Clamps

    AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.

    Product
    Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2025·2024-11-20

    Medline urine collection kits recalled for non-sterile specimen containers

    Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2025·2024-11-20

    Halyard ANGIO PACK surgical kits recalled for loose metal fragments

    AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.

    Product
    Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0131-2025·2024-11-20

    Home Chef Asian Style Chicken Stir Fry Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Asian Style Chicken Stir Fry due to potential contamination with Listeria monocytogenes. The recall affects 31,424 consumer units distributed across the United States.

    Product
    Home Chef Asian Style Chicken Stir Fry, Net Wt. 13 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430852, all lot codes
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-0358-2025·2024-11-20

    Medline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers

    Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2025·2024-11-20

    Halyard Knee Arthroscopy Packs recalled due to loose metal flakes

    AVID Medical recalls Halyard Knee Arthroscopy Packs due to loose metal flakes that could detach from forceps and clamps. Metal fragments may enter the surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2025·2024-11-20

    Halyard Pacemaker Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard Pacemaker Pack surgical kits because sponge forceps and towel clamps contain loose metal flakes that could detach and enter patient surgical sites.

    Product
    Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2025·2024-11-20

    Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage

    Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.

    Product
    Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2025·2024-11-20

    Halyard Laparotomy GYN Packs recalled due to loose metal flakes

    AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.

    Product
    Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2025·2024-11-20

    Surgical Instruments Recalled Due to Potential Metal Flake Contamination

    AVID Medical recalled Halyard POST PARTUM TUBAL LIGATION surgical kit components due to loose metal flakes that could detach from sponge forceps and towel clamps. Metal flakes entering a patient's surgical site could cause local or foreign body reactions.

    Product
    Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2025·2024-11-20

    Clean Catch Kit specimen containers recalled for sterility labeling failure

    Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.

    Product
    Clean Catch Kit, SKU DYKM1833A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2025·2024-11-20

    Surgical instruments recalled for loose metal flake contamination risk

    AVID Medical is recalling Halyard RAD PACK medical convenience kits containing sponge forceps and towel clamps. Small metal flakes may detach and enter surgical sites, potentially causing foreign body or local tissue reactions.

    Product
    Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0383-2025·2024-11-20

    Medical Drainage Pack Components Recalled for Potential Metal Fragments

    AVID Medical is recalling the Halyard IR Abcess Drainage Pack due to sponge forceps and towel clamps that may have loose metal flakes. Metal flakes could detach and enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2025·2024-11-20

    Medical Convenience Kits Recalled for Detachable Metal Flakes in Surgical Instruments

    AVID Medical is recalling Halyard Shoulder Pack medical convenience kits because the sponge forceps and towel clamps contain loose metal flakes that could detach and enter a patient's surgical site during use, potentially causing foreign body reactions.

    Product
    Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2025·2024-11-20

    Halyard Angio Tray surgical kits recalled for loose metal flakes

    AVID Medical recalls Halyard ANGIO TRAY (Model VAPX021-05) surgical kits due to potential loose metal flakes on forceps and clamps that could enter surgical sites and cause local or foreign body reactions.

    Product
    Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2025·2024-11-20

    Stryker electrosurgical smoke evacuation pencils recalled for unintended activation risk

    Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2025·2024-11-20

    Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes

    AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2025·2024-11-20

    Surgical Sponge Forceps and Towel Clamps Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of local or foreign body reactions.

    Product
    Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2025·2024-11-20

    Halyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.

    Product
    Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2025·2024-11-20

    IMAGEnet 6 Ophthalmic Data System Hood Report Display Issue

    IMAGEnet 6 ophthalmic software's Hood Report overlay can mislead clinicians about clinical correlations unsupported by evidence. Affects 3,144 units nationwide.

    Product
    The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2025·2024-11-20

    Halyard IR Biopsy Pack recalled for loose metal flakes in surgical kit

    AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2025·2024-11-20

    SafeControl Bed Handset May Move Unexpectedly After Power Restoration

    The SafeControl handset component of Sentida beds may revert to an active mode after power restoration, potentially causing unintended bed movement. Consumers should ensure beds are safely positioned before power interruptions.

    Product
    SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2025·2024-11-20

    Stryker Smoke Evacuation Pencils Recalled for Unintended Activation Risk

    Stryker is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units because they may activate unexpectedly when plugged in, creating a risk of electrical burns to patients and physicians.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2025·2024-11-20

    Halyard ORTHO PACK surgical instrument kits recalled due to metal flakes

    AVID Medical is recalling Halyard ORTHO PACK kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2025·2024-11-20

    MEERA CL Mobile Operating Table Control Malfunction Recall

    The MEERA CL mobile operating table may experience error code 50037 that stops table movement during use, causing surgical procedure delays. Getinge recalled 342 units distributed worldwide.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2025·2024-11-20

    Surgical instrument bundle recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VAG hysterectomy instrument bundles due to loose metal flakes on surgical instruments that could contaminate surgical sites.

    Product
    Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2025·2024-11-20

    Medical Convenience Kits Recalled for Detachable Metal Flakes

    AVID Medical recalls Halyard TAH-BUNDLE medical kits with sponge forceps and towel clamps. Loose metal flakes may detach and enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2025·2024-11-20

    Halyard SAMMC ANGIOGRAPHY Medical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard SAMMC ANGIOGRAPHY medical convenience kits due to loose metal flakes on sponge forceps and towel clamps. Metal flakes may enter surgical sites, potentially causing local reactions or foreign body complications.

    Product
    Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2025·2024-11-20

    Medical surgical kits recalled for loose metal flakes in instruments

    AVID Medical is recalling Halyard CYSTO PDS medical convenience kits due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could enter a surgical site and cause foreign body reactions.

    Product
    Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2025·2024-11-20

    Urine kit specimen containers recalled for non-sterile condition

    Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.

    Product
    URINE KIT, SKU DYKM1845; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2025·2024-11-20

    UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling

    MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.

    Product
    UA KIT, SKU DYKM1690A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2025·2024-11-20

    Operating Table May Stop Unexpectedly During Surgery Due to Control Error

    MEERA CL mobile operating tables may experience an error code that causes the table to stop moving unexpectedly during surgery, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2025·2024-11-20

    Halyard Shoulder Medical Kit recalled for loose metal flakes in surgical components

    AVID Medical is recalling Halyard shoulder surgical kits due to loose metal flakes that could detach and enter surgical sites. Metal debris could cause local or foreign body reactions.

    Product
    Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2025·2024-11-20

    Halyard Surgical Kit Components May Shed Metal Flakes

    AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2025·2024-11-20

    Halyard EYE PLASTIC TRAY Medical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.

    Product
    Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2025·2024-11-20

    Surgical forceps and clamps recalled due to potential metal flake contamination

    AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.

    Product
    Halyard ENT - Medical convenience kits Model Number: VMED011-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2025·2024-11-20

    Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk

    AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.

    Product
    Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2025·2024-11-20

    Halyard Pacemaker Instrument Packs Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.

    Product
    Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2025·2024-11-20

    Medical convenience kits recalled due to detachable metal flakes

    AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2025·2024-11-20

    Baxter Spectrum IQ Infusion Pump Door May Not Close Fully

    Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0425-2025·2024-11-20

    Halyard Urology Laparotomy Pack surgical instruments recalled for detachable metal flakes

    AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.

    Product
    Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2025·2024-11-20

    Medical Laboratory Kit Recalled Due to Non-Sterile Specimen Container

    Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.

    Product
    Lab Kit, SKU DYLAB1018; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2025·2024-11-20

    Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes

    Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2025·2024-11-20

    Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

    Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

    Product
    Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2025·2024-11-20

    Halyard PACK MINOR surgical instrument kits recalled for metal flake contamination

    AVID Medical is recalling Halyard PACK MINOR surgical kits due to loose metal flakes that may detach from forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2025·2024-11-20

    IV Fluid Container Bags Recalled for Potential Leaks During Filling

    The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.

    Product
    SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2025·2024-11-20

    Surgical instrument kits recalled for potential loose metal flake hazard

    Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.

    Product
    Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2025·2024-11-20

    Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.

    Product
    Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2025·2024-11-20

    Halyard C Section Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

    Product
    Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2025·2024-11-20

    Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
    Category
    Medical Device
    Distribution
    Distributed nationwide

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