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

3051–3075 of 39948

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
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-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-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-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
ModerateFDA (Devices)·Z-0010-2026·2025-10-08
Allura Xper FD20/15 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 300 Allura Xper FD20/15 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0004-2026·2025-10-08
Allura Xper FD10 OR Table systems recalled over BIOS battery depletion
Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Product
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2026·2025-10-08
Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2672-2025·2025-10-08
Vital sign monitors recalled over blood pressure measurement error messages
Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.
Product
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2026·2025-10-08
Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Product
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2025·2025-10-08
Vein ablation generators recalled over software falsely flagging working catheters
BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.
Product
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2026·2025-10-08
Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Product
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0014-2026·2025-10-08
Allura Xper CV20 X-ray systems recalled after BIOS battery halts startup
Philips is recalling 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.
Product
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2026·2025-10-08
Allura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0011-2026·2025-10-08
Allura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.
Product
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2026·2025-10-08
Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion
Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Product
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0026-2026·2025-10-08
Surgical instrument attachments recalled after standard and long versions were mislabeled
Aesculap is recalling one ELAN 4 Fixed Duraguard unit after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0027-2026·2025-10-08
Surgical guard attachments recalled after long and standard labels were swapped
Aesculap is recalling three ELAN 4 Fixed Duraguard Long units after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Product
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0013-2026·2025-10-08
Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion
Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0015-2026·2025-10-08
Allura Centron cardiovascular X-ray systems recalled over BIOS battery depletion
Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.
Product
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2026·2025-10-08
Allura Xper FD20 Biplane OR Table systems recalled for BIOS battery failure
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0006-2026·2025-10-08
Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion
Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2026·2025-10-08
Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Product
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2640-2025·2025-10-08
Hip stems recalled over potential mix of two catalog numbers in packaging
Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.
Product
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Category
Medical Device
Distribution
0 states

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3051–3075 of 39948