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

35501–35525 of 40325

ModerateFDA (Devices)·Z-1745-2014·2014-07-02
Philips Brilliance CT Big Bore Recalled for Radio Frequency Emission Tolerance Issues
Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.
Product
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1840-2014·2014-07-02
Siemens LANTIS System Recall for Unvalidated Operating System Risks
Siemens is recalling 108 LANTIS linear accelerator systems because using the software with unvalidated operating systems can cause data corruption and incorrect treatment records.
Product
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1855-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used in dialysis systems because they contain aluminum levels exceeding internal specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 The SAK is one of the disposables used with NxStage PureFlow SL…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2014·2014-07-02
Anspach Recalls Arthroscopic Suture Anchor Assemblies for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 68 arthroscopic suture anchor assemblies because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1843-2014·2014-07-02
BioFire FilmArray Blood Culture Identification Panel Recalled for False Positives
BioFire is recalling the FilmArray Blood Culture Identification Panel due to an increased risk of false positive results when used with specific blood culture bottles.
Product
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1906-2014·2014-07-02
Anspach Recalls 113 MRI Fluted Routers for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 113 MRI fluted routers because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1864-2014·2014-07-02
Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Hardware
Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of stainless steel nuts.
Product
Ingenia 3.0T, magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1889-2014·2014-07-02
Anspach eMax2 Console Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling eMax2 Console units because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1897-2014·2014-07-02
Anspach Custom Pneumatic Motor Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1862-2014·2014-07-02
Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Nut Components
Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.
Product
Ingenia 3.0T R5, magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2014·2014-07-02
Anspach Recalls 5mm Coarse Diamond Ball Devices for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 50 units of 5mm Coarse Diamond Ball devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1896-2014·2014-07-02
Anspach Custom Device SC2102 Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Device SC2102 units because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1884-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Manufacturing Inconsistencies
The Anspach Effort, Inc. is recalling specific custom medical devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1845-2014·2014-07-02
Siemens RAD Fluoro Uro System Recalled for Image Malfunction
Siemens is recalling 76 RAD Fluoro Uro Systems because a software malfunction can cause images to appear very dark, potentially leading to unnecessary repeat examinations.
Product
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1919-2014·2014-07-02
Anspach Custom Autolube Food Guard Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Autolube Food Guard devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1913-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1880-2014·2014-07-02
Anspach eMax Hand Control Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling three eMax Hand Control units because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1883-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1861-2014·2014-07-02
NxStage Dialysate Sack Recalled for Excess Aluminum Levels
NxStage Medical is recalling 91 cases of dialysate sacks because aluminum levels exceeded internal specifications. The product was distributed in the US and internationally.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1907-2014·2014-07-02
Anspach Recalls 130 MRI Fluted Balls Due to Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 130 units of 4mm Fluted Balls for MRI because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1915-2014·2014-07-02
Anspach Recalls Arthroscopic Knotless Suture Anchors for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 100 units of Arthroscopic Knotless Suture Anchors because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1888-2014·2014-07-02
Anspach Modified MDA Tube Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Modified MDA Tubes with MA-D20 Attachments because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1902-2014·2014-07-02
Anspach Custom QD11 Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling three Custom QD11 Attachments because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1830-2014·2014-07-02
Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect
Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.
Product
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Category
Medical Device
Distribution
1 state

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35501–35525 of 40325