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

20026–20050 of 27682

SevereFDA (Devices)·Z-1408-2017·2017-03-15
FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise
The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.
Product
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1432-2017·2017-03-15
Siemens PRIMUS HI and Mevatron M2 Linear Accelerators Recalled for Weld Defect
Siemens is recalling 35 PRIMUS HI and Mevatron M2 linear accelerators due to a defective weld seam that could cause overhead suspensions to fall and injure people.
Product
PRIMUS HI and Mevatron M2/Primus Mid-Energy, 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
SevereFDA (Devices)·Z-1433-2017·2017-03-15
Siemens Medical Recalls 35 MEVATRON M 6700 Linear Accelerators
Siemens Medical Solutions USA is recalling 35 MEVATRON M 6700 linear accelerators due to a defective weld seam that could cause the overhead suspension to fall and injure a patient or other person.
Product
MEVATRON M 6700 (MX) 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
SevereFDA (Devices)·Z-1430-2017·2017-03-15
Villa Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment
Villa Sistemi Medicali is recalling 65 Apollo EZ x-ray systems because the footrest detached from the table, causing a patient to fall.
Product
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1429-2017·2017-03-15
Apollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard
Villa Sistemi Medicali is recalling 65 Apollo DRF x-ray systems because the footrest can detach, causing patients to fall from the table.
Product
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1437-2017·2017-03-15
Siemens MEVATRON KD-2 Linear Accelerators Recalled for Defective Weld Seams
Siemens is recalling 35 MEVATRON KD-2 linear accelerators due to defective weld seams that could break and cause the overhead suspension to fall, posing a risk of severe injury.
Product
MEVATRON KD-2, 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
SevereFDA (Devices)·Z-1436-2017·2017-03-15
Siemens Medical Linear Accelerators Recalled for Defective Overhead Suspension Welds
Siemens is recalling 35 linear accelerator systems due to defective weld seams that could cause overhead suspensions to fall, posing a risk of severe injury.
Product
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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
SevereFDA (Devices)·Z-1434-2017·2017-03-15
Siemens Medical Linear Accelerators Recalled for Defective Weld Seams
Siemens is recalling 35 MEVATRON M 6730/6740 linear accelerators because defective weld seams on overhead suspensions could break and fall, posing a risk of severe injury.
Product
MEVATRON M 6730/6740 (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
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
SevereFDA (Devices)·Z-1368-2017·2017-03-08
Windstone Medical Packaging Recalls Shoulder Arthroscopy Packs Due to Sterility Risk
Windstone Medical Packaging is recalling 606 Shoulder Arthroscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part…
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-1329-2017·2017-03-08
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Product
Lap/Pelviscopy Pack, part number PSS3256(B
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-1251-2017·2017-03-08
Olympus Recalls URF-P6 Uretero-reno Fiberscopes Due to Tissue Trauma Risk
Olympus is recalling URF-P6 and URF-P6R uretero-reno fiberscopes due to adverse events involving tissue trauma and stuck insertion tubes reported in similar devices.
Product
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0788-2017·2017-03-08
Medtronic SynchroMed II Software Card Recall for Priming Bolus Function
Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.
Product
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1379-2017·2017-03-08
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because splits or holes may compromise sterility.
Product
Upper Torso Tray, part number PSS1554(B
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-1280-2017·2017-03-08
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may compromise sterility.
Product
Catheter Pack, part number AMS4399(A
Category
Medical Device
Distribution
26 states

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20026–20050 of 27682