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.

25201–25225 of 50443

HighFDA (Devices)·Z-2152-2019·2019-08-14
SenTec Membrane Changer Recall Due to Electrolyte Application Defect
SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.
Product
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2161-2019·2019-08-14
Centurion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise
Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.
Product
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2019·2019-08-14
MED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures
MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.
Product
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2019·2019-08-14
Centurion Medical Products Recalls Sterile Fluoro SSP Trays Due to Packaging Concerns
Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.
Product
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2019·2019-08-14
SenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect
SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.
Product
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2019·2019-08-14
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.
Product
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2140-2019·2019-08-14
Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect
Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2200-2019·2019-08-14
Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits
Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.
Product
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2221-2019·2019-08-14
ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets
ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.
Product
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2153-2019·2019-08-14
SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
Product
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1659-2019·2019-08-14
RXQ Compounding Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Fentanyl and Bupivacaine syringes nationwide due to a lack of assurance of sterility.
Product
FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0207-89
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1665-2019·2019-08-14
RXQ Compounding Recalls Hydromorphone Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling hydromorphone syringes because the company cannot ensure the product is sterile.
Product
HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89; b) 55 ML NDC 70731-0114-95] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2019·2019-08-14
Gk Photonics Spectrum Laser Projection Series Recalled for Safety Defect
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation exposure.
Product
Spectrum Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2096-2019·2019-08-14
Gk Photonics Logolas Laser Projectors Recalled for Safety Interlock Defect
Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.
Product
Logolas Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2148-2019·2019-08-14
Olympus MAJ-209 Single Use Suction Valves Recalled for Potential Malfunction
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
Product
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2019·2019-08-14
Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.
Product
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2165-2019·2019-08-14
Centurion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.
Product
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2019·2019-08-14
Integra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
Product
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
Category
Medical Device
Distribution
5 states
HighFDA (Drugs)·D-1664-2019·2019-08-14
RXQ Compounding Recalls Hydrogen Peroxide Injectable Due to Sterility Concerns
RXQ Compounding LLC is recalling Hydrogen Peroxide 3% Injectable PFV because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0907-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-2088-2019·2019-08-14
HEB Taco Seasoning Mix Recalled Due to Potential Salmonella Contamination
CH Guenther & Sons, Inc. is recalling HEB Taco Seasoning Mix because the cumin ingredient may be contaminated with Salmonella.
Product
HEB Taco Seasoning Mix 25% Less Sodium Net Wt. 1.25 OZ, H-E-B San Antonio TX UPC 0 41220 79609 0
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-2138-2019·2019-08-14
MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
Product
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1636-2019·2019-08-14
RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization
RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.
Product
Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0975-50
Category
Drug
Distribution
Distributed nationwide