Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

42076–42100 of 50511

HighFDA (Devices)·Z-0687-2014·2014-01-15
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. The affected units were distributed worldwide.
Product
78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 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-0672-2014·2014-01-15
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
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 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-0640-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries is recalling 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 #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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0642-2014·2014-01-15
Smiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles
Smiths Medical is recalling specific lots of Hypodermic Needle-Pro Fixed Needle Insulin Syringes because visible orange or brown particulate was found on the needles.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2014·2014-01-15
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
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 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-0681-2014·2014-01-15
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 devices may leak.
Product
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 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-0667-2014·2014-01-15
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
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0633-2014·2014-01-15
Welch Allyn Propaq LT Series Monitors Recalled for Potential Operational Interruption
Welch Allyn is updating software on Propaq LT Series monitors because rare hardware or software faults could interrupt device operations.
Product
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0656-2014·2014-01-15
Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
The Anspach Effort, Inc. is voluntarily removing the microMax Pneumatic Drill System because the outer hose may rupture without warning if airflow is blocked.
Product
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Category
Medical Device
Distribution
Distributed nationwide
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
HighNHTSA·14V009000·2014-01-15
Triumph Recalls 2012-2014 Tiger and Trophy Motorcycles for ECU Defect
Triumph is recalling 2012-2014 Tiger and Trophy motorcycles because a faulty electronic control unit may cause the engine to shut down unexpectedly, increasing crash risk.
Product
TRIUMPH — TRIUMPH TIGER, TROPHY
Category
Vehicle
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