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

5176–5200 of 39844

CriticalFDA (Devices)·Z-0382-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0375-2025·2024-11-27
Baxter peritoneal dialysis transfer set recalled for PCB exposure risk
Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0378-2025·2024-11-27
Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure
Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0482-2025·2024-11-27
Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
Product
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0379-2025·2024-11-27
Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0377-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0373-2025·2024-11-27
Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk
Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2025·2024-11-27
Posi-Stop 23-Gauge Injection Needles recalled for manufacturing debris blockage
Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.
Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2025·2024-11-27
Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.
Product
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0493-2025·2024-11-27
Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.
Product
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0480-2025·2024-11-27
CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0491-2025·2024-11-27
Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
Product
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0478-2025·2024-11-27
CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure
Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0479-2025·2024-11-27
CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure
CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2025·2024-11-27
Medical Device Homocysteine Test Assay Recalled for Calibration Defects
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
Product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0483-2025·2024-11-27
Hip Prosthesis Mislabeled with Wrong Size; Risk of Joint Instability
Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.
Product
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shel
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0468-2025·2024-11-27
Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow
Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.
Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0492-2025·2024-11-27
Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect
Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.
Product
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0497-2025·2024-11-27
Philips Vue PACS Diagnostic Viewer Software Recall for Calculation Errors
Philips is recalling Vue PACS Diagnostic Viewer software versions 12.1.5 to 12.2.8.454 because a defect may cause incorrect ischemic map calculations, potentially leading to misdiagnosis.
Product
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2025·2024-11-27
Posi-Stop 25-Gauge Injection Needles Recalled for Manufacturing Debris Blockage
Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.
Product
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2025·2024-11-27
CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2025·2024-11-27
Acrobat-i Vacuum Stabilizer System Recalled for Sterile Barrier Compromise
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Product
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2025·2024-11-27
Posi-Stop Injection Needles Recalled Due to Manufacturing Debris Blocking Injection Flow
Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.
Product
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2025·2024-11-27
Smiths Medical CADD-Solis AC adapter input plugs pose electrical shock risk
Smiths Medical is recalling 156,400 CADD-Solis AC adapters due to damaged or broken input plugs that may expose metal contacts. The affected adapters could pose a risk of electrical shock or fire.
Product
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0471-2025·2024-11-27
Injection Needles Recalled for Manufacturing Debris Blocking Medication Flow
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris inside the needle shaft that blocks medication flow. The affected lot was distributed across multiple US states and Canada.
Product
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

5176–5200 of 39844