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 the agency’s own highest classification or reported deaths or serious injuries, 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

32651–32675 of 40325

HighFDA (Devices)·Z-1963-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
Product
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1852-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2015·2015-07-08
Covidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2015·2015-07-08
Medtronic Recalls Navigated Cannulated Taps Due to Cleaning Injury Risk
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
Product
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1982-2015·2015-07-08
GE Healthcare Recalls Innova IGS 540 Angiographic X-ray Systems
GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1964-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.
Product
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheters for Antimicrobial Defects
The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1980-2015·2015-07-08
GE Healthcare Recalls Innova IGS 520 Angiographic X-ray Systems
GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2015·2015-07-08
GE Healthcare Recalls Innova IGS 620 Angiographic X-ray Systems
GE Healthcare is recalling three Innova IGS 620 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1965-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
Product
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2015·2015-07-08
Zimmer Recalls Natural Knee II Revision Femoral Stems Due to Sterility Breach
Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.
Product
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed worldwide with expiry dates of February 2018 and earlier.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1932-2015·2015-07-08
Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results
Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.
Product
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1908-2015·2015-07-08
Covidien Recalls Chronic Catheters That May Not Meet Antimicrobial Specifications
Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2015·2015-07-08
Roche Creatinine Plus Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.
Product
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2015·2015-07-08
Palindrome HSI Chronic Catheter Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2015·2015-07-08
FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects
The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1977-2015·2015-07-08
GE Healthcare Recalls Innova 2121IQ Angiographic X-ray Systems
GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2015·2015-07-08
Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk
Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.
Product
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1918-2015·2015-07-08
New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy
New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.
Product
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1978-2015·2015-07-08
GE Healthcare Recalls Innova 3100IQ Angiographic X-ray Systems
GE Healthcare is recalling six Innova 3100IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1981-2015·2015-07-08
GE Healthcare Recalls Innova IGS 530 Angiographic X-ray Systems
GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide

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