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.

42101–42125 of 50511

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
HighFDA (Devices)·Z-0697-2014·2014-01-15
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
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 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
HighCPSC·14710·2014-01-15
Honda and Columbia Walk-Behind Lawnmowers Recalled for Laceration Hazard
American Honda is recalling specific 21-inch walk-behind lawnmowers because the engine stop switch can malfunction, allowing the blade to keep rotating after the control lever is released.
Product
Walk-behind 21" lawnmowers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0670-2014·2014-01-15
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
78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0684-2014·2014-01-15
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 devices may leak.
Product
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 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-0673-2014·2014-01-15
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" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 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-0623-2014·2014-01-15
Aesculap Recalls Hi-Line XXS Handpieces Due to Possible Failure
Aesculap, Inc. is recalling 14 Hi-Line XXS handpieces due to a possible failure of the device. The handpieces are used to hold burrs that cut and shape bone.
Product
Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0682-2014·2014-01-15
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
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 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-0696-2014·2014-01-15
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
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0657-2014·2014-01-15
Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the handpiece hose can rupture without warning if airflow is blocked.
Product
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2014·2014-01-15
Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles
Smiths Medical is recalling 29-gauge insulin syringes due to visible orange or brown particulate on the needles. The recall covers 506,925 units distributed in the US, Canada, Italy, and Spain.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 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 (Food)·F-1378-2014·2014-01-15
Baugher Ranch Organic Almonds Recalled for Potential Metal Fragments
Baugher Ranch Organics is recalling 80 cases of organic almonds due to a broken metal detector wire that may have introduced metal fragments into the product.
Product
Organic Almonds: Baugher Ranch Organics; Certified Organic by California Organic Farmers May Contain occasional Shell fragments. Keep Refrigerated; 25 lbs. Baugher Farms, Orland, CA
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0649-2014·2014-01-15
Optimedica Catalys Precision Laser System Recalled for Transformer Heating Risk
Optimedica is recalling 78 Catalys Precision Laser Systems worldwide due to a risk of transformer heating and smoke.
Product
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2014·2014-01-15
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
13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 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-0669-2014·2014-01-15
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 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 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-0661-2014·2014-01-15
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
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿, NanoClave¿ T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile…
Category
Medical Device
Distribution
14 states