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

33576–33600 of 40325

ModerateFDA (Devices)·Z-1056-2015·2015-02-11
Siemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall
Siemens is recalling 230 ACUSON SC2000 ultrasound systems because a bolt holding the control panel may fail, preventing the panel from locking into position.
Product
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1058-2015·2015-02-11
Puritan Bennett 980 Ventilator Recalled for Occasional GUI Resets
Covidien is voluntarily recalling 418 Puritan Bennett 980 ventilators due to occasional graphical user interface resets lasting approximately 30 seconds.
Product
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1048-2015·2015-02-11
Intuitive Surgical Recalls da Vinci Si Wall Charts for Sterilization Inconsistency
Intuitive Surgical is recalling 1,034 da Vinci Si Wall Charts because they contained incorrect sterilization dry time information inconsistent with the User Manual.
Product
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1057-2015·2015-02-11
Medtronic Recalls KYPHON EXPRESS Osteo Introducer System Due to Labeling Error
Medtronic is recalling 239 units of the KYPHON EXPRESS Osteo Introducer System because the packaging may contain the wrong instrument tips.
Product
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1047-2015·2015-02-11
Fresenius Crit Line in a Clip Monitor Recalled for Display Misinterpretation
Fresenius Medical Care is recalling 35 Crit Line in a Clip monitors due to a potential for misinterpretation of the Blood Volume slope graphic display.
Product
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1050-2015·2015-02-11
Hospira Recalls Plum A+ Infusion Systems with Cracked Pole Clamp Assemblies
Hospira Inc. is recalling 102 Plum A+ Infusion Systems because cracked pole clamp assemblies prevent the devices from securely attaching to IV poles.
Product
Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1043-2015·2015-02-11
Stryker Recalls Trident PSL Hip Shells Missing Dome Hole Plugs
Stryker Howmedica Osteonics is recalling seven units of Trident PSL HA Solid Back 50 mm hip shells because the dome hole plugs were missing from the packages.
Product
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1033-2015·2015-02-11
Express Diagnostics Recalls DrugCheck Ketamine Dip Tests for False Positives
Express Diagnostics is recalling DrugCheck Ketamine Dip Tests because they may produce false positive results, leading to incorrect screening outcomes.
Product
DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1037-2015·2015-02-11
FDA Recalls 16cm Minimally Invasive Attachment Due to Incorrect Color Bands
The Anspach Effort, Inc. is recalling 8 units of the MIA16-G1 Minimally Invasive Attachment because customer complaints indicated the color bands were not correct.
Product
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1013-2015·2015-02-04
Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk
Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.
Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1022-2015·2015-02-04
Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure
Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.
Product
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1019-2015·2015-02-04
Sunrise Medical Recalls Three Zippie Zone Pediatric Wheelchairs Due to Handle Defect
Sunrise Medical is recalling three Zippie Zone Pediatric Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.
Product
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2015·2015-02-04
Philips BrightView MRI Systems Recalled for Unintended Movement
Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.
Product
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2015·2015-02-04
Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.
Product
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2015·2015-02-04
Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors
Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.
Product
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1031-2015·2015-02-04
Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction
Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.
Product
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1020-2015·2015-02-04
Sunrise Medical Recalls Six Quickie Q7 Adult Rigid Wheelchairs
Sunrise Medical is recalling six Quickie Q7 Adult Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.
Product
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1023-2015·2015-02-04
Beckman Coulter Lipase Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.
Product
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1012-2015·2015-02-04
Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling
Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.
Product
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1024-2015·2015-02-04
Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.
Product
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1026-2015·2015-02-04
Beckman Coulter Lactate Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.
Product
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1021-2015·2015-02-04
Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage
Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.
Product
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1009-2015·2015-02-04
Synthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling
Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.
Product
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1015-2015·2015-02-04
Fresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies
Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.
Product
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1025-2015·2015-02-04
Beckman Coulter Cholesterol Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.
Product
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Category
Medical Device
Distribution
Distributed nationwide

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33576–33600 of 40325