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

32726–32750 of 40325

HighFDA (Devices)·Z-1972-2015·2015-07-08
Siemens Recalls Syngo Imaging Software Due to Display and Measurement Errors
Siemens is recalling Syngo Imaging software versions V30 and V31 because safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non-square pixel size.
Product
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1953-2015·2015-07-08
Sheffield Pharmaceuticals Recalls LUBRI GEL Due to B. cepacia Contamination
Sheffield Pharmaceuticals is recalling specific lots of Dr. Sheffield's LUBRI GEL personal lubricant after testing revealed high counts of gram-positive rods and B. cepacia.
Product
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1973-2015·2015-07-08
GE Healthcare Recalls Optima IGS 320 Angiographic X-ray Systems
GE Healthcare is recalling three Optima IGS 320 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Optima IGS 320. 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-1935-2015·2015-07-08
Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.
Product
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA is recalling Palindrome HSI 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 HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification
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 14.5 Fr x 44cm Item Code: 8888146144P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1914-2015·2015-07-08
Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues
Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.
Product
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter…
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1984-2015·2015-07-08
GE Healthcare Recalls Innova IGS 630 Angiographic X-ray Systems
GE Healthcare is recalling eight Innova IGS 630 angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 630. 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
ModerateFDA (Devices)·Z-1930-2015·2015-07-08
Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits
Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.
Product
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1929-2015·2015-07-08
Roche Triglycerides GPO Test Recalled for Potential Drug Interference
Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.
Product
Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1889-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI 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 HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1959-2015·2015-07-08
Siemens ACUSON SC2000 Ultrasound Systems Recalled for Data Loss
Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.
Product
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1933-2015·2015-07-08
Siemens SOMATOM Emotion 16 CT Scanners Recalled for Broken Gantry Screws
Siemens is recalling 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.
Product
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1942-2015·2015-07-08
Siemens EasyLink Data Management System Recalled for Software Limitations
Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.
Product
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1890-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
The FDA is recalling Palindrome HSI 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 HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2015·2015-07-08
Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.
Product
Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2015·2015-07-08
Palindrome Precision HSI Chronic Catheter Recalled for Antimicrobial Specification Failure
Covidien LLC 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 28cm Item Code: 8888128459P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2015·2015-07-08
Intuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes
Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.
Product
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1928-2015·2015-07-08
Roche LDL-Cholesterol Test Recalled for Potential Drug Interference
Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.
Product
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2015·2015-07-08
Siemens CentraLink Data Management System Software Recall
Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.
Product
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1869-2015·2015-07-08
Covidien Recalls Palindrome Precision SI Chronic Catheter Kits
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 19cm Item Code: 8888145062CP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1927-2015·2015-07-08
Roche LDL-Cholesterol Test Recalled for Potential Drug Interference
Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.
Product
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1915-2015·2015-07-08
DePuy Synthes Titanium Recon Screws Recalled for Incorrect Insert
Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.
Product
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1916-2015·2015-07-08
RTI Surgical Recalls Mislabeled Bullet-Tip PEEK VBR Implants
RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.
Product
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1946-2015·2015-07-08
Axis-Shield Homocysteine Reagent Recalled for Performance Deterioration
Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test results.
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product…
Category
Medical Device
Distribution
Distributed nationwide

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32726–32750 of 40325