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

27151–27175 of 40357

HighFDA (Devices)·Z-1752-2017·2017-04-12
Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error
Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.
Product
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1707-2017·2017-04-12
Philips IntelliVue MX4O Monitor Recall for Alarm Failure
Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.
Product
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2017·2017-04-12
Centurion Convenience Kits Recalled Due to Sterile Packaging Breach
Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.
Product
CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1741-2017·2017-04-12
Recall of Sterile Eye Pads Due to Compromised Sterility Barrier
Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.
Product
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2017·2017-04-12
Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach
Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.
Product
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1751-2017·2017-04-12
Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error
Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.
Product
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1730-2017·2017-04-12
Centurion Medical Recalls Post-Op Eye Trays Due to Sterile Packaging Breach
Centurion Medical Products is recalling 476 Post-Op Eye Trays because the sterile eye pads inside may have had a packaging breach.
Product
POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1735-2017·2017-04-12
Centurion Convenience Kits Recalled Due to Potential Sterile Packaging Breach
Centurion Medical Products is recalling 1,692 Convenience Kits containing eye pads due to a potential breach in sterile packaging.
Product
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1743-2017·2017-04-12
Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier
FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.
Product
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1732-2017·2017-04-12
Centurion Convenience Kits Recalled for Potential Sterile Packaging Breach
Centurion Medical Products is recalling 588 Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.
Product
OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1750-2017·2017-04-12
Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect
Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.
Product
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1742-2017·2017-04-12
Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier
Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.
Product
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2017·2017-04-12
BD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk
Becton Dickinson is recalling specific lots of BD Vacutainer Buffered Sodium Citrate blood collection tubes because stoppers may pull out during use.
Product
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2017·2017-04-12
Recall of Sterile Eye Pads Due to Compromised Sterility Barrier
Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.
Product
Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2017·2017-04-12
Centurion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns
Centurion Medical Products is recalling 45 post-operative ophthalmic dressing kits because the eye pads inside may have had a breach in sterile packaging.
Product
POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1747-2017·2017-04-12
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. 02419937, SMN 10333349 (1-pack/50 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-1715-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpreted instructions may cause tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish 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-1721-2017·2017-04-12
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 German 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-1728-2017·2017-04-12
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 Spanish 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
ModerateFDA (Devices)·Z-1713-2017·2017-04-12
BioMerieux Recalls NucliSENS Lysis Buffer Due to Colored Eluates
BioMerieux SA is recalling NucliSENS Lysis Buffer because colored eluates were observed during whole blood extractions.
Product
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1710-2017·2017-04-12
Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests.
Product
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 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-1708-2017·2017-04-12
Philips eCare Coordinator Software Recalled for Data Integrity Defects
Philips Visicu is recalling eCare Coordinator software due to a defect that may cause missing or redundant data to be saved without user notification.
Product
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1706-2017·2017-04-12
Philips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems because electronic markers may be placed at the wrong anatomical position when images are moved between views.
Product
Mobile Diagnostic X-Ray System with Digital Panel
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1719-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Errors
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 French 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-1723-2017·2017-04-12
Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Issues
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Japanese 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

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27151–27175 of 40357