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 deaths or serious injuries are reported, 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

3426–3450 of 5038

SevereFDA (Devices)·Z-1606-2018·2018-05-09
Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.
Product
Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1609-2018·2018-05-09
Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation
Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.
Product
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1604-2018·2018-05-09
Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation
Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.
Product
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1541-2018·2018-05-09
PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.
Product
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn s
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1602-2018·2018-05-09
Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports
Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.
Product
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1605-2018·2018-05-09
Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.
Product
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1607-2018·2018-05-09
Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure
Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.
Product
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1532-2018·2018-05-02
BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1477-2018·2018-05-02
Ion Beam Applications Recalls Proteus Proton Beam Therapy Systems
Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.
Product
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1420-2018·2018-04-25
Autochair Milford Smartbase Recalled Due to Leg Folding Hazard
Autochair is recalling Milford Smartbase units because a weak spring and misaligned locking pin caused legs to fold, dropping a person.
Product
Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1411-2018·2018-04-25
Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect
Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Product
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1409-2018·2018-04-25
Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect
Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1461-2018·2018-04-25
Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk
Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.
Product
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1460-2018·2018-04-25
Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk
Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.
Product
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1314-2018·2018-04-18
Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks
Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.
Product
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use o
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1365-2018·2018-04-18
Fresenius Liberty Select Cycler Recalled for Software Overfill Risk
Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.
Product
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1351-2018·2018-04-18
W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls
W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.
Product
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1318-2018·2018-04-18
Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts
Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.
Product
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1236-2018·2018-04-04
Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing
Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.
Product
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1249-2018·2018-04-04
Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues
Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
Product
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1260-2018·2018-04-04
Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments
Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
Product
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1244-2018·2018-04-04
Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues
Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.
Product
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1247-2018·2018-04-04
Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns
Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
Product
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1262-2018·2018-04-04
Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories
Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.
Product
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1253-2018·2018-04-04
Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues
Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
Product
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state

How to read this listing

Filters

3426–3450 of 5038