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

31551–31575 of 40449

HighFDA (Devices)·Z-0324-2016·2015-12-02
Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage
Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.
Product
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0320-2016·2015-12-02
Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue
Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.
Product
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2016·2015-12-02
NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.
Product
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2016·2015-12-02
NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
Product
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0338-2016·2015-12-02
Masimo Recalls Rainbow Reusable Sensors Due to Inaccurate Readings
Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.
Product
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2016·2015-12-02
Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results
Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.
Product
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0332-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0319-2016·2015-12-02
Siemens Syngo Imaging Software Recall for Version VB36D_HF02
Siemens Medical Solutions is recalling three units of Syngo Imaging software to provide supplementary information regarding the release of Version VB36D_HF02.
Product
Syngo Imaging VB36D_HF02. Radiological image processing system.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0321-2016·2015-12-02
Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools
Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.
Product
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0329-2016·2015-12-02
Palindrome Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
Product
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0330-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2016·2015-12-02
Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents
Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.
Product
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2016·2015-12-02
BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination
Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.
Product
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0325-2016·2015-12-02
Philips MRI Systems Recalled for Reversed Image Order in MobiView Software
Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.
Product
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0322-2016·2015-12-02
Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling
Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.
Product
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds…
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0328-2016·2015-12-02
Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies
Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.
Product
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0323-2016·2015-12-02
Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert
Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.
Product
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-0274-2016·2015-11-25
Hill-Rom Recalls 100 Low Bed Units Due to Patient Injury Reports
Hill-Rom is voluntarily recalling 12,251 Hill-Rom 100 Low Beds because patients were injured while exiting the beds at the lowest position setting.
Product
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0230-2016·2015-11-25
Event Medical Recalls Inspiration Ventilators Due to Power Board Failure
Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.
Product
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0277-2016·2015-11-25
Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0284-2016·2015-11-25
Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure
FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.
Product
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0295-2016·2015-11-25
Fresenius 132 Gallon Dry Acid Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
Product
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2016·2015-11-25
Fresenius GranuFlo Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
Product
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0285-2016·2015-11-25
Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure
ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.
Product
Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

31551–31575 of 40449