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

25076–25100 of 27722

HighFDA (Devices)·Z-1717-2014·2014-06-11
Siemens Ysio Systems Recalled for Potential Unintended Radiation Release
Siemens is recalling 433 Ysio radiographic systems because excessive cleaning liquid usage may cause a short circuit, leading to unintended radiation release.
Product
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2014·2014-06-11
Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues
Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.
Product
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1704-2014·2014-06-11
Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk
Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.
Product
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1354-2014·2014-06-04
Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure
Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.
Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1660-2014·2014-06-04
Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns
Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.
Product
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1661-2014·2014-06-04
Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect
Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.
Product
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1672-2014·2014-06-04
Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift
Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.
Product
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1671-2014·2014-06-04
Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift
Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.
Product
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1658-2014·2014-06-04
Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference
Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.
Product
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2014·2014-06-04
Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk
Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.
Product
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1664-2014·2014-06-04
Beaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle
Beaver-Visitec International Inc. is recalling Visitec Anterior Chamber Cannulas because some units contain a sharp tip needle instead of a blunt tip cannula.
Product
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1652-2014·2014-06-04
Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories
Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.
Product
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1539-2014·2014-05-28
Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk
Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.
Product
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2014·2014-05-28
Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error
Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.
Product
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1523-2014·2014-05-28
Maquet Datascope Intra-Aortic Balloon Pump Recall for Fan Assembly Failure
Maquet Datascope is recalling 11,881 Intra-Aortic Balloon Pump units worldwide due to a potential fan assembly failure that could cause the power supply to overheat and shut down without warning.
Product
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2014·2014-05-28
Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error
Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc.…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1645-2014·2014-05-28
Siemens 550 TxT Treatment Table Recalled for Calibration Loss
Siemens Medical Solutions is recalling 120 550 TxT Treatment Tables because they may lose calibration during treatment, posing a risk of patient mistreatment.
Product
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1644-2014·2014-05-28
Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks
Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.
Product
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1634-2014·2014-05-28
Terumo Recalls CDI Blood Parameter Monitoring System for Inaccurate Readings
Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.
Product
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1628-2014·2014-05-28
Philips Recalls Lithium Ion Batteries for IntelliVue Patient Monitors
Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.
Product
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1638-2014·2014-05-28
Siemens MAMMOMAT Inspiration PC Monitor Holder Recall for Injury Risk
Siemens is recalling five MAMMOMAT Inspiration mammography units because the PC monitor holder can break, causing the monitor to fall and potentially injure users.
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-1639-2014·2014-05-28
Fresenius Recalls Naturalyte Liquid Bicarbonate Concentrate Due to Contamination
Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate bottles due to potential contamination. The product is used in hemodialysis machines.
Product
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1643-2014·2014-05-28
Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks
Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.
Product
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1624-2014·2014-05-28
Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect
Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1626-2014·2014-05-28
Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect
Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
Category
Medical Device
Distribution
Distributed nationwide

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25076–25100 of 27722