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

25626–25650 of 27722

HighFDA (Devices)·Z-0703-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0707-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0636-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries LLC is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0695-2014·2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.
Product
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0648-2014·2014-01-15
GE Healthcare Recalls Patient Data Modules Due to Heat Buildup Risk
GE Healthcare is recalling 17,444 Patient Data Modules used with SOLAR 8000 and Transport Pro monitors. The recall addresses a potential safety issue where fluid ingress can cause heat buildup.
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0671-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0638-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades may be exposed, compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0659-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0621-2014·2014-01-15
Integra Small Rickham-Style Reservoirs Recalled for Bent or Broken Connectors
Integra LifeSciences is recalling 194 packages of Small Rickham-Style Reservoirs due to bent or broken connectors found after opening the sterile package.
Product
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining…
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0634-2014·2014-01-15
Invacare Recalls Tracer IV Wheelchairs Due to Warped Wheels
Invacare is recalling 227 Tracer IV wheelchairs in Michigan because the wheels were warped and wobbled when rolled.
Product
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0701-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0664-2014·2014-01-15
ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage
ICU Medical is recalling specific lots of NanoClave Stopcocks because a small percentage of the devices may leak.
Product
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0647-2014·2014-01-15
On Site Gas Systems POGS 33C Portable Oxygen System Recall
On Site Gas Systems is recalling 198 POGS 33C portable oxygen generation systems in Pennsylvania because the heat exchanger hose may fail.
Product
On Site Gas Systems POGS 33C Portable Oxygen Generation System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0637-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0668-2014·2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.
Product
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0529-2014·2014-01-15
EOS Imaging Recalls EOS System X-ray Digital Radiography Devices
EOS Imaging is recalling 22 EOS System X-ray digital radiography units installed in the US due to a discrepancy between the operator-set collimation and the actual X-ray beam collimation.
Product
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0693-2014·2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.
Product
10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0698-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0689-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0686-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0639-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, compromising sterility and posing an injury risk.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2014·2014-01-15
Fresenius 2008 Series Hemodialysis Machines Recalled for Saline Bag Filling Issues
Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because saline bags may fill inappropriately during setup and recirculation.
Product
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0625-2014·2014-01-15
Siemens HB1C Flex Reagent Cartridges Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling HB1C Flex Reagent Cartridges due to positive bias and frequent 'Above Assay Range' flags.
Product
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0651-2014·2014-01-15
Midmark Vantage Panoramic X-Ray System Recalled for Firmware Error
Midmark Corp dba Progeny Inc is recalling 58 Vantage Panoramic X-Ray systems due to a firmware error that may cause the unit's column to continue moving vertically after the control button is released.
Product
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular…
Category
Medical Device
Distribution
14 states

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25626–25650 of 27722