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

2151–2175 of 27346

HighFDA (Devices)·Z-0020-2026·2025-10-08
Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2026·2025-10-08
Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2673-2025·2025-10-08
Ophthalmic imaging software recalled over measured areas smaller than actual values
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.
Product
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2026·2025-10-08
Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2026·2025-10-08
Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2026·2025-10-08
Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0017-2026·2025-10-08
Dental implants recalled after import under non compliant temperature and storage conditions
S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.
Product
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0030-2026·2025-10-08
Radiology software recalled because reports may not display fully when viewed
Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.
Product
Change Healthcare Radiology Solutions software version 14.2.2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0016-2026·2025-10-08
Washer disinfectors recalled over overheating risk from incorrect pressure calibration
Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.
Product
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2026·2025-10-08
Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0036-2026·2025-10-08
Vascular grafts recalled after delamination reports prompt instructions for use update
W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.
Product
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2671-2025·2025-10-08
Antimicrobial susceptibility test cards recalled over false colistin resistance results
bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.
Product
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export o
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2566-2025·2025-10-01
Intubation trays recalled after laryngoscope handle lights failed to illuminate
Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.
Product
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-2568-2025·2025-10-01
Automated Impella Controller units recalled for pump performance risk
Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.
Product
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
Category
Medical Device
Distribution
17 states
SevereFDA (Devices)·Z-2567-2025·2025-10-01
Medline Medical Convenience Kits with Defective Laryngoscope Handles
Medline Industries is recalling specific medical convenience kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles because the light fails to illuminate as intended, potentially affecting resuscitation and airway management procedures.
Product
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2594-2025·2025-10-01
Intravenous solution sets recalled after customer reports of tubing separation
Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.
Product
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2025·2025-10-01
Allura Xper FD10 OR Table recalled over ageing power supply and drive
Philips Allura Xper FD10 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2 units are affected.
Product
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2597-2025·2025-10-01
Big Bore CT systems recalled because patient table may descend unexpectedly
Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.
Product
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2627-2025·2025-10-01
Allura Xper FD20 Biplane recalled over component deterioration affecting motorized movements
Philips Allura Xper FD20 Biplane systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 268 units are affected.
Product
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2025·2025-10-01
MyDay toric contact lenses recalled after one lot used invalid sterilization
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2025·2025-10-01
Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2025·2025-10-01
Philips Brilliance iCT SP CT Systems Patient Support Table Descent
Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2626-2025·2025-10-01
Allura Xper FD20 systems recalled over component deterioration halting motorized movements
Philips Allura Xper FD20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2,114 units are affected.
Product
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2635-2025·2025-10-01
Allura CV20 systems recalled over internal component deterioration disabling motorized movement
Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.
Product
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2598-2025·2025-10-01
Brilliance iCT systems recalled over ball screw misalignment dropping the couch
Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Category
Medical Device
Distribution
Distributed nationwide

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2151–2175 of 27346