The Recall Desk

Archive

November 2024 recalls

510 recalls were announced in November 2024.

What the numbers show

Critical
11
Severe
108
High
341
Moderate
39
Low
11

Of the 510 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

101–200 of 510

  • SevereUSDA FSIS·030-2024-EXP·2024-11-21

    Yu Shang Food Recalls Ready-to-Eat Meat and Poultry Due to Listeria

    Yu Shang Food, Inc. is recalling approximately 72,240 pounds of ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination.

    Product
    Yushang Food Inc. — Yu Shang Food, Inc. Recalls Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    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
  • 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
  • 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
  • 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
  • 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
  • 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 (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 (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
  • 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-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
  • SevereFDA (Devices)·Z-0327-2025·2024-11-20

    Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure

    Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.

    Product
    Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
    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-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
  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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…
    Category
    Food
    Distribution
    1 state
  • 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-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-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 (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-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
  • 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-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
  • 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 (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
  • 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 (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-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 (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-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 (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 (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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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-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
  • HighFDA (Devices)·Z-0400-2025·2024-11-20

    Surgical procedure kits recalled due to loose metal flakes in instruments

    AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2025·2024-11-20

    Halyard Extremity Pack Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.

    Product
    Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2025·2024-11-20

    Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.

    Product
    Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2025·2024-11-20

    Surgical hip procedure kit recalled for incomplete product seals

    Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.

    Product
    CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
    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-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-0392-2025·2024-11-20

    Halyard cardiac surgical kit recalled for loose metal flakes risk

    AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2025·2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0130-2025·2024-11-20

    Home Chef Chicken Street Taco Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Chicken Street Taco meal kits due to Listeria monocytogenes contamination in the cooked chicken. Approximately 24,072 units distributed across 31 states are affected.

    Product
    Home Chef Chicken Street Taco, Net Wt. 9.93 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430435, all lot codes
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-0450-2025·2024-11-20

    Surgical kits recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
    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-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-0427-2025·2024-11-20

    Surgical forceps and clamps recall due to potential loose metal flakes

    AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.

    Product
    Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
    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-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-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 (Food)·F-0132-2025·2024-11-20

    Frozen Potato Wedges Recalled for Undeclared Wheat Allergen

    JR Simplot's frozen seasoned potato wedges are being recalled because the product contains wheat but the label does not declare this allergen. The affected product was distributed to retailers in Pennsylvania only.

    Product
    Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES…
    Category
    Food
    Distribution
    1 state
  • 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-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-0346-2025·2024-11-20

    Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.

    Product
    Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2025·2024-11-20

    Surgical Kit Components Recalled for Potential Metal Fragment Detachment

    AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.

    Product
    Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2025·2024-11-20

    Halyard MINOR PACK Medical Kits Recalled for Loose Metal Fragments in Instruments

    AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, potentially causing local or foreign body reactions.

    Product
    Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2025·2024-11-20

    MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage

    The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.

    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: 700001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2025·2024-11-20

    Halyard surgical kit recalled for loose metal flakes in forceps and clamps

    AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2025·2024-11-20

    Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes

    AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2025·2024-11-20

    VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling

    The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.

    Product
    VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; 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-0371-2025·2024-11-20

    Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat

    Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.

    Product
    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into…
    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…
    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-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-0412-2025·2024-11-20

    Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes

    AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.

    Product
    Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
    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-0449-2025·2024-11-20

    Halyard ENDOVASCULAR surgical kits recalled for loose metal flakes

    Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.

    Product
    Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2025·2024-11-20

    IV Fluid Bags Recalled Due to Leaking During Filling

    The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.

    Product
    Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-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-0443-2025·2024-11-20

    Halyard Pacemaker Drape Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.

    Product
    Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2025·2024-11-20

    Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments

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

    Product
    Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
    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-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-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-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-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 (Food)·F-0124-2025·2024-11-20

    Westby Cheese Curds Recalled Due to Potential E. coli Contamination

    Westby Cooperative Creamery is recalling Westby Cheese Curds due to potential generic E. coli contamination. Affected products have a sell-by or expiration date of November 26, 2024.

    Product
    Westby Cheese Curds, UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667. White, Yellow, and Mixed Curds are packaged in 12 oz. (340g) bags or in 10 lb. bulk boxes.
    Category
    Food
    Distribution
    1 state
  • 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-0393-2025·2024-11-20

    Halyard Anterior Hip Pack surgical kits recalled due to loose metal flakes

    AVID Medical is recalling Halyard Anterior Hip Pack surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach, enter a patient's surgical site undetected, and cause local or foreign body reactions.

    Product
    Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2025·2024-11-20

    Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes

    AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.

    Product
    Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2025·2024-11-20

    MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur

    The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and 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: 720001F0
    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-0340-2025·2024-11-20

    IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall

    The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.

    Product
    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; 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-0385-2025·2024-11-20

    Medical Surgical Kit Recalled for Potential Loose Metal Flake Hazard

    AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.

    Product
    Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.

    Product
    Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; 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-0465-2025·2024-11-20

    Medline Iris Scissors Recalled for Potential Sterility Barrier Compromise

    Medline is recalling 69,611 single-use iris scissors because the tip protector may fall off during packaging, compromising the sterile barrier. Affected units were distributed nationwide to 20 states.

    Product
    Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
    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-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-0345-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.

    Product
    Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; 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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2025·2024-11-20

    IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim

    Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.

    Product
    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2024.