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

7426–7450 of 13652

HighFDA (Devices)·Z-0818-2024·2024-02-07
Cardiac surgical kits recalled due to improper sterilization exposure
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
Product
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2024·2024-02-07
Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail
Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.
Product
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2024·2024-02-07
Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation
Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.
Product
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0917-2024·2024-02-07
Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.
Product
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2024·2024-02-07
Philips Achieva 1.5T MRI system recalled for defective coil seal
Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade patients during scanning.
Product
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2024·2024-02-07
Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0865-2024·2024-02-07
GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts
GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.
Product
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0901-2024·2024-02-07
Knee replacement poly insert recalled due to material oxidation risk
Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.
Product
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2024·2024-02-07
Cortera Spinal Fixation System screws recalled for incorrect dimensions
XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0935-2024·2024-02-07
Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2024·2024-02-07
Knee replacement component recalled due to potential material oxidation
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0882-2024·2024-02-07
SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0869-2024·2024-02-07
Knee replacement patella component recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.
Product
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0831-2024·2024-02-07
Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0966-2024·2024-02-07
Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration
Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.
Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0969-2024·2024-02-07
Medline Blood Culture Tray Adult recalled for incomplete component labeling
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
Product
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0968-2024·2024-02-07
Medline Blood Culture Kits recalled for inaccurate expiration dating
Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
Product
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0964-2024·2024-02-07
Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Product
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0868-2024·2024-02-07
TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation
MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0837-2024·2024-02-07
FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy
Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.
Product
Terragene Bionova PCD (PCD222-C)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0866-2024·2024-02-07
Surgical needle holders distributed with incorrect product labels
Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.
Product
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0797-2024·2024-01-31
Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage
C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.
Product
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0772-2024·2024-01-31
VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.
Product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0790-2024·2024-01-31
Bard Nasogastric Sump Tube with ENFit Recalled for Reduced Suction and Drainage
C.R. Bard is recalling 3,400 units of Bard Nasogastric Sump Tube with ENFit due to reports of inadequate suction, decompression, and drainage during use affecting patients requiring nasogastric care.
Product
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0814-2024·2024-01-31
TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System
The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.
Product
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Category
Medical Device
Distribution
Distributed nationwide

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7426–7450 of 13652