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.

23001–23025 of 50430

HighFDA (Devices)·Z-2126-2020·2020-06-03
Thermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers
Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.
Product
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2150-2020·2020-06-03
Biomet Recalls Vanguard Knee System Tibial Bearings Due to Endotoxin Levels
Biomet, Inc. is recalling 46 units of Vanguard Knee System tibial bearings because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2020·2020-06-03
Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk
Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.
Product
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2020·2020-06-03
Nikon Metrology XTH Cabinet X-Ray Systems Recalled for Shielding Defect
Nikon Metrology is recalling 110 XTH cabinet x-ray systems because interior shielding may detach, potentially causing x-ray emissions to exceed safety limits.
Product
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2103-2020·2020-06-03
Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2158-2020·2020-06-03
Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Epix latis GRASPER devices because a protruding rivet may cause tissue damage during use.
Product
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-2131-2020·2020-06-03
Intuitive Surgical Recalls da Vinci SP Cameras Due to Residual Soil
Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.
Product
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2020·2020-06-03
Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections
Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.
Product
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0961-2020·2020-06-03
Absorb Health Joint Relief Recalled for Missing Shellfish Allergen Labeling
Absorb Health LLC is recalling 70 bottles of Advanced Joint Relief capsules because the ingredient panel failed to list a shellfish allergen.
Product
Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC 28462 UPC 79056992863
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-2155-2020·2020-06-03
Biomet Recalls Vanguard M Partial Knee System MonoBlock Tibial Trays
Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.
Product
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2020·2020-06-03
Inpeco Accelerator a3600 Automation System Recalled for Safety Switch Delay
Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
Product
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2161-2020·2020-06-03
Applied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Clip Applier Kits because a protruding rivet on the laparoscopic grasper may catch tissue, causing damage.
Product
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-2153-2020·2020-06-03
Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels
Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.
Product
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2020·2020-06-03
Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections
Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.
Product
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2020·2020-06-03
Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.
Product
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2020·2020-06-03
Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation
Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
Product
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290)…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2102-2020·2020-06-03
Cardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking
Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2143-2020·2020-06-03
Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk
Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.
Product
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2020·2020-06-03
Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels
Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2020·2020-06-03
Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures
Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.
Product
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2139-2020·2020-06-03
Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.
Product
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2020·2020-06-03
Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.
Product
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2020·2020-06-03
Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.
Product
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2020·2020-06-03
Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.
Product
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2020·2020-06-03
Cardinal Health Recalls Kangaroo 924 Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo 924 Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Category
Medical Device
Distribution
0 states