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.

41101–41125 of 50511

HighFDA (Devices)·Z-1718-2014·2014-06-11
Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration
Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical issues.
Product
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1712-2014·2014-06-11
Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty
Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during surgery.
Product
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1993-2014·2014-06-11
Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein
Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars because the chocolate coating contains undeclared milk protein.
Product
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.
Category
Food
Distribution
41 states
HighFDA (Devices)·Z-1700-2014·2014-06-11
Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch
Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Product
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1721-2014·2014-06-11
Siemens CT Systems Recalled Due to Rubber Damper Degradation Risk
Siemens Medical Solutions is recalling 345 CT systems because a rubber damper may degrade and break, potentially causing motor mounting plates to loosen and injuring operators or patients.
Product
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1716-2014·2014-06-11
Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation
Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.
Product
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1699-2014·2014-06-11
Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections
Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.
Product
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2014·2014-06-11
Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage
Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.
Product
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2014·2014-06-11
Hospira Infusion Pumps Recalled for Door Roller Assembly Defect
Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.
Product
Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2014·2014-06-11
FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
Product
Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1723-2014·2014-06-11
Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination
Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.
Product
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a…
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-2008-2014·2014-06-11
Rockman Raw Peanuts Recalled for Mold and Missing Allergen Labeling
Rockman Company USA is recalling raw peanuts due to mold contamination and missing allergen, nutrition, and ingredient information.
Product
Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as "PEANUT" on packaging. Product labeling reads in part: "ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT…
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1678-2014·2014-06-11
Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors
Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.
Product
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2014·2014-06-11
Siemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk
Siemens is recalling 37 AXIOM Luminos dRF diagnostic imaging systems because electrostatic discharges may trigger unintended movement, posing a danger to patients and personnel.
Product
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric…
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1694-2014·2014-06-11
Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise
Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.
Product
Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·14V313000·2014-06-11
Blue Bird Recalls 2008-2013 All American School Buses for Thermostat Defect
Blue Bird is recalling 2008-2013 All American school buses because a thermostat design flaw may cause a heater hose to rupture, allowing hot coolant to enter the passenger compartment.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2014·2014-06-11
Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect
Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.
Product
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2014·2014-06-11
Philips CT Scanners Recalled for Disengaged Service Latch
Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.
Product
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1991-2014·2014-06-11
Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein
Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars because the chocolate coating contains undeclared milk protein.
Product
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages.
Category
Food
Distribution
41 states
HighFDA (Devices)·Z-1679-2014·2014-06-11
Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems
Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.
Product
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1701-2014·2014-06-11
Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch
Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Product
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1673-2014·2014-06-11
Bayer Medrad Continuum MR Infusion System Recall for Damaged Locking Pins
Bayer is recalling non-wireless Medrad Continuum MR Infusion Systems shipped before March 2008 due to potentially damaged locking pins in the bracket.
Product
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1984-2014·2014-06-11
Royal Rye Recalls Sourdough Dark Rye Bread for Undeclared Soy
Royal Rye LLC is recalling KrustaVita Bread of Life Sourdough Dark Rye Bread due to undeclared soy. The product was distributed in Oregon and Washington.
Product
KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1708-2014·2014-06-11
CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure
CP Medical is recalling one lot of Monoswift PGCL absorbable sutures because they failed to meet USP minimum tensile strength requirements.
Product
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1686-2014·2014-06-11
Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise
Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.
Product
Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide