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

27476–27500 of 40357

SevereFDA (Devices)·Z-1435-2017·2017-03-15
Siemens MEVATRON M 7400/7440 Linear Accelerators Recalled for Defective Welds
Siemens is recalling 35 MEVATRON M 7400/7440 linear accelerators because a defective weld seam could break, causing the overhead suspension to fall and potentially injure patients or others.
Product
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2017·2017-03-15
Prism Medical A625 Manual Lifts Recalled for Premature Strap Breakage
ErgoSafe Products is recalling 21 Prism Medical A625 manual lifts because two units had straps break prematurely during internal testing at maximum load.
Product
A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1414-2017·2017-03-15
Becton Dickinson Recalls EpiCenter Plus Software Version 6.20A
Becton Dickinson is recalling EpiCenter Plus Microbiology Data Management System software version 6.20A because outdated translation tables may cause mis-identification of organisms.
Product
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1401-2017·2017-03-15
Boston Scientific Recalls AngioJet Ultra 5000 A Console Foot Switches
Boston Scientific is recalling AngioJet Ultra 5000 A Console foot switches because they may stick during use, causing the device to operate continuously and undesirably.
Product
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1420-2017·2017-03-15
Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference
Siemens is recalling IMMULITE Progesterone test kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.
Product
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2017·2017-03-15
Encore Medical Recalls RSP Impaction Fixtures Due to Material Wear
Encore Medical is recalling 626 RSP Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.
Product
RSP Impaction Fixture
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1406-2017·2017-03-15
Prism Medical A625 Patient Lifts Recalled for Premature Strap Failure
Prism Medical is recalling 76 A625 patient lifts because two units had straps break prematurely during internal testing at maximum load.
Product
A-series lift - A625 Manual Part No. 324117. Prism Medical.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1399-2017·2017-03-15
Parker Medical Recalls Left Double Lumen Endobronchial Tubes
Parker Medical is recalling specific lots of Left Double Lumen Endobronchial Tubes because the single lung isolation feature did not function as intended.
Product
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2017·2017-03-15
See Clear Company Recalls Color Contact Lenses for Sterility and Labeling Issues
The See Clear Company is recalling 119,829 units of color contact lenses because they may not be sterile and may have incorrect lot numbers or expiry dates.
Product
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2017·2017-03-15
Siemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results
Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.
Product
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2017·2017-03-15
Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Footrest Detachment
Villa Sistemi Medicali is recalling 65 Juno DRF x-ray systems because the footrest can detach from the table, causing patients to fall.
Product
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1407-2017·2017-03-15
MicroAire K-Wires Recalled for Incorrect Product Labeling
MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.
Product
MicroAire K-Wires
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1411-2017·2017-03-15
Mako Surgical Recalls MAKO RIO THA Application User Guides
Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.
Product
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1426-2017·2017-03-15
Merge Unity PACS Software Recalled for Missing Demographic Data
Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.
Product
DR Systems Unity PACS software, now known as Merge Unity PACS
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1412-2017·2017-03-15
Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear
Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.
Product
Turon Impaction Fixture
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1400-2017·2017-03-15
Remel Haemophilus Test Medium Recalled for Poor Organism Growth
Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.
Product
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1402-2017·2017-03-15
Metrex Recalls CaviWipes Extra Large Due to Packaging Contamination
Metrex Research is recalling CaviWipes Extra Large surface disinfectants because they may have been contaminated during the packaging process.
Product
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1403-2017·2017-03-15
Merge Cardio software recalled for incorrect measurement units in reports
Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1424-2017·2017-03-15
Siemens Biograph Mobile PET/CT Recall for Missing Instructions
Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.
Product
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1431-2017·2017-03-15
Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures
Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.
Product
Merge PACS software. The firm name on the label is Merge Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1438-2017·2017-03-15
Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure
Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.
Product
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1422-2017·2017-03-15
Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions
Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.
Product
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1425-2017·2017-03-15
Siemens Biograph Mobile PET/CT Recall for Missing Instructions
Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.
Product
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1419-2017·2017-03-15
Siemens Progesterone Test Recalled Due to DHEA-S Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.
Product
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1418-2017·2017-03-15
Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.
Product
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used…
Category
Medical Device
Distribution
Distributed nationwide

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