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.

19576–19600 of 50413

HighFDA (Devices)·Z-2245-2021·2021-08-18
FDA Recalls Blood Culture Identification Panel for False Negative Results
BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.
Product
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2237-2021·2021-08-18
Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results
Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.
Product
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21183·2021-08-18
Marin Mountain Bicycles Recalled for Fall and Crash Hazards
Marin Mountain Bikes is recalling approximately 2,100 Model Year 2021 mountain bicycles because the bottom bracket can break during use, causing loss of control and fall hazards. The firm has received nine reports of broken bottom brackets but no injuries have been reported.
Product
Mountain Bicycles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2238-2021·2021-08-18
Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size
Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-2236-2021·2021-08-18
Orthopedic drill bit recalled for corrosion particle contamination risk
NEOSTEO cannulated drill bits are being recalled due to corrosion traces on the laser marking that could release particles into the surgical field. The recall affects Lot 243-20 distributed in New Jersey.
Product
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2021·2021-08-18
SARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.
Product
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2021·2021-08-18
ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.
Product
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2250-2021·2021-08-18
Exactech BIOLOX Delta Femoral Head Hip Prosthesis Recalled for Device Marking Mismatch
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2021·2021-08-18
Arcos Hip Implant Component Recalled for Potential Device Failure
Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2260-2021·2021-08-18
Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk
Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require revision surgery.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2208-2021·2021-08-18
Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance
The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.
Product
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
Category
Medical Device
Distribution
12 states
HighFDA (Food)·F-0858-2021·2021-08-18
Molly and Me Pecans Recalled for Undeclared Soy
Molly and Me Pecans praline pecans are being recalled because they contain undeclared soy, which poses a risk to consumers with soy allergies.
Product
MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED &…
Category
Food
Distribution
28 states
HighFDA (Devices)·Z-2243-2021·2021-08-18
Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.
Product
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2224-2021·2021-08-18
Codman Raney Scalp Clips recalled for compromised sterile barrier packaging
Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.
Product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2021·2021-08-18
Covidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk
Covidien recalls 96 units of its Sonicision Reusable Generator surgical device due to a manufacturing assembly error that may cause device malfunction, thermal burns, or tissue damage. The defect may also disable the audio indicator that signals device activation.
Product
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2021·2021-08-18
Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure
Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2021·2021-08-18
Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk
Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2021·2021-08-18
Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2021·2021-08-18
Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
Product
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2246-2021·2021-08-18
Mislabeled Cutting Electrode May Contain Wrong Electrode Type
Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.
Product
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2021·2021-08-18
FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion
Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2021·2021-08-18
Beckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
Product
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2021·2021-08-18
Arcos Modular Hip Implant Cone Bodies Recalled for Fretting Corrosion
Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Category
Medical Device
Distribution
Distributed nationwide