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

4076–4100 of 5111

SevereFDA (Devices)·Z-0561-2016·2016-01-06
Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall
Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.
Product
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0557-2016·2016-01-06
Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error
Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.
Product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0442-2016·2015-12-30
Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.
Product
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0543-2016·2015-12-30
Philips Recalls Cardinal Health Tiny Toes Infant Heel Warmers
Philips Electronics North America is recalling Cardinal Health Tiny Toes infant heel warmers because they may cause first and second degree burns.
Product
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0440-2016·2015-12-30
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests due to the potential for reporting erroneous results, specifically false susceptible results for Piperacillin/Tazobactam.
Product
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0424-2016·2015-12-30
Aesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery
Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.
Product
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0448-2016·2015-12-30
Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk
Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.
Product
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0482-2016·2015-12-30
Cardica Recalls MicroCutter Xchange 30 Blue Cartridges Due to Firing Defect
Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Cartridges because they may fail to fire staples completely, potentially causing incomplete tissue transection or anastomosis during surgery.
Product
MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient devic
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-0483-2016·2015-12-30
Cardica Recalls MicroCutter Xchange 30 Blue Curved Tip Cartridges
Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Curved Tip Cartridges because incomplete staple firing may result in incomplete tissue transection or anastomosis during surgery.
Product
MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-0422-2016·2015-12-30
Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage
Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.
Product
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0360-2016·2015-12-23
Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure
Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.
Product
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0443-2016·2015-12-23
Remel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs
Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.
Product
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0393-2016·2015-12-23
Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure
Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.
Product
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0394-2016·2015-12-23
Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure
Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.
Product
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0374-2016·2015-12-16
Philips IntelliVue Information Center iX Software Recall for Alarm Failure
Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.
Product
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, param
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0354-2016·2015-12-09
Philips Xper Vascular System Monitor Ceiling Suspension Recall
Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0351-2016·2015-12-09
Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and throm
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2016·2015-12-09
Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0349-2016·2015-12-09
Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0271-2016·2015-12-02
Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
Product
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0337-2016·2015-12-02
NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system 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 -High Permeability Hemodialysis System Model no. NX1000-4
Category
Medical Device
Distribution
0 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-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-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

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