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

27776–27800 of 40357

HighFDA (Devices)·Z-1127-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.
Product
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2017·2017-02-08
Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening
Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.
Product
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.
Product
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2017·2017-02-08
Organ Preservation Solution Recalled for Potential Bacterial Contamination
Organ Recovery Systems is recalling SPS-1 Static Preservation Solution bags due to potential bacterial contamination.
Product
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2017·2017-02-08
Medtronic Strata II Valves Recalled for Pressure Discrepancies
Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.
Product
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2017·2017-02-08
Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results
Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.
Product
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2017·2017-02-08
Covidien Nellcor SpO2 Forehead Sensor Recalled for Latex Labeling Error
FDA is recalling 7,453 units of the Covidien Nellcor SpO2 Forehead Sensor because the label incorrectly states the product is latex-free, while the headband contains latex.
Product
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.
Product
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2017·2017-02-08
Olympus Vanta XRF Analyzers Recalled for LED Warning Light Failure
Olympus is recalling Vanta VCR and VMR XRF analyzers because the LED warning lights may fail to illuminate during X-ray emission.
Product
Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1134-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.
Product
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2017·2017-02-08
Siemens Recalls IMMULITE PSA Kits Due to Negative Bias
Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.
Product
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2017·2017-02-08
Implant Direct Recalls SwishTapered Implants Due to Packaging Error
Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.
Product
SwishTapered Implant
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1130-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.
Product
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.
Product
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1109-2017·2017-02-08
Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives
Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.
Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1115-2017·2017-02-08
Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors
Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.
Product
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1114-2017·2017-02-08
Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies
Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.
Product
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1116-2017·2017-02-08
Siemens Syngo.plaza PACS Software Recall for Issue Resolution
Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.
Product
Syngo.plaza, picture archiving and communications system.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1117-2017·2017-02-08
Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.
Product
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1118-2017·2017-02-08
Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error
Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.
Product
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0923-2017·2017-02-01
Philips Allura Xper FD10 X-ray System Recalled for Loose Screws
Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.
Product
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1065-2017·2017-02-01
Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.
Product
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-1063-2017·2017-02-01
Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.
Product
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0925-2017·2017-02-01
Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws
Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.
Product
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1064-2017·2017-02-01
Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.
Product
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states

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27776–27800 of 40357