Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

776–800 of 5027

SevereFDA (Devices)·Z-0821-2025·2025-01-22
Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
Product
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0824-2025·2025-01-22
ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0714-2025·2025-01-22
Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
Product
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0715-2025·2025-01-22
Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup
Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.
Product
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0716-2025·2025-01-22
Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk
Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.
Product
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0764-2025·2025-01-22
Medline Fluid Delivery Sets incorrectly assembled with wrong drip chamber
Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.
Product
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2025·2025-01-22
Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
Product
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0826-2025·2025-01-22
CRT-P Pacemakers Recalled for Potential Safety Mode Initiation Risk
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
Product
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0905-2025·2025-01-22
Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Product
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0712-2025·2025-01-15
Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Product
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0795-2025·2025-01-15
Oxygen Concentrator May Catch Fire or Melt During Use
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Product
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0763-2025·2025-01-15
Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0711-2025·2025-01-15
VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
Product
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0708-2025·2025-01-01
Cardiac Monitoring Software Failed to Properly Route ECG Events
Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.
Product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0682-2025·2025-01-01
Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results
Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.
Product
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0683-2025·2025-01-01
Blood glucose ketone meter software bug causes erroneous result transmission
Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.
Product
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0681-2025·2025-01-01
Glucose Hospital Meter Software Bug Transmits Inaccurate Results
StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.
Product
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0656-2025·2024-12-25
Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery
Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.
Product
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0659-2025·2024-12-25
Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
Product
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0668-2025·2024-12-25
FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.
Product
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0660-2025·2024-12-25
Optikon Bipolar Pencil surgical tool recalled for tube failure risk
FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.
Product
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0667-2025·2024-12-25
Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.
Product
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0662-2025·2024-12-25
Exacta External Drainage System Stopcocks May Leak or Crack
Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.
Product
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0658-2025·2024-12-25
Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment
Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.
Product
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0661-2025·2024-12-25
Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.
Product
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
Category
Medical Device
Distribution
Distributed nationwide

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