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

27101–27125 of 40233

ModerateFDA (Devices)·Z-1718-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1748-2017·2017-04-12
Siemens ADVIA Centaur BR Assay Recalled for Potential Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.
Product
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1704-2017·2017-04-12
Beckman Coulter Recalls AU680 and AU5800 Rack ID Labels Due to Mismatch
Beckman Coulter is recalling Rack ID Labels for AU680 and AU5800 analyzers because the displayed ID number and barcode do not match.
Product
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1711-2017·2017-04-12
Beckman Coulter Recalls UniCel DxC 600i SYNCHRON Access Clinical Systems
Beckman Coulter is recalling specific UniCel DxC 600i SYNCHRON Access Clinical Systems because a circuit board defect can cause the device to stop running and cancel tests.
Product
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1749-2017·2017-04-12
Siemens ADVIA Centaur BR Assay Recalled for Potential Syphilis Assay Interference
Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.
Product
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1712-2017·2017-04-12
Siemens ADVIA Chemistry Enzyme 2 Calibrator Recalled for Positive Bias
Siemens is recalling ADVIA Chemistry Enzyme 2 Calibrators due to a positive bias of up to 41% in AST and AST_c assay results.
Product
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1738-2017·2017-04-12
Agfa Healthcare Recalls DX-D600 Imaging Packages Due to Dent Marker Defect
Agfa Healthcare is recalling 81 DX-D600 imaging packages because a dent marker may fall from the overhead rail.
Product
DX-D600 - DXD Imaging Package
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-1727-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Card Issues
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Swedish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1720-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1725-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Korean SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1417-2017·2017-04-05
Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Failure to Deliver Therapy
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.
Product
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1575-2017·2017-04-05
FDA Recalls 170 Sterile Laparoscopic Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 170 sterile laparoscopic procedure trays because a light glove component can split during application, breaking the sterile field.
Product
Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1668-2017·2017-04-05
Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Product
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1497-2017·2017-04-05
Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk
Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.
Product
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1561-2017·2017-04-05
FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.
Product
Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1646-2017·2017-04-05
FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1580-2017·2017-04-05
Recall of Regard Open Heart Procedure Kits Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1613-2017·2017-04-05
FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1699-2017·2017-04-05
Stryker Visum LED Surgical Lighting System Recalled for Mounting Defect
Stryker is recalling 292 Visum LED Surgical Lighting systems because missing screws and user overloading may cause the equipment to fall.
Product
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1578-2017·2017-04-05
Recall of Regard Sterile Laparotomy Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 30 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1639-2017·2017-04-05
Recall of Regard Sterile Lap PK Spohn Custom Procedure Trays
Resource Optimization & Innovation LLC is recalling 3,000 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1656-2017·2017-04-05
Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 249 sterile robotic hysterectomy kits because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1644-2017·2017-04-05
Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1581-2017·2017-04-05
Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 96 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Product
Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1663-2017·2017-04-05
Recall of Sterile Arthroscopy Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Category
Medical Device
Distribution
2 states

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27101–27125 of 40233