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.

36701–36725 of 50504

HighFDA (Devices)·Z-0728-2016·2016-02-10
Philips INTEGRIS Allura X-Ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
Product
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2016·2016-02-10
Philips INTEGRIS Allura X-ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
Product
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0744-2016·2016-02-10
Acist Medical Systems Recalls BT2000 and CPT2000 Automated Manifold Kits
Acist Medical Systems is recalling BT2000 and CPT2000 Automated Manifold Kits due to reports of air ingress into the manifold.
Product
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0711-2016·2016-02-10
Philips Recalls Allura Xper FD20 Biplane Systems Due to Image Display Error
Philips is recalling Allura Xper FD20 Biplane systems because a software issue may cause still images to be misinterpreted as live images.
Product
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0520-2016·2016-02-10
Signature Breads French Dinner Rolls Recalled for Metal Fragments
Signature Breads, Inc. is recalling Piantedosi French Dinner Rolls because the product may contain metal fragments. The recall affects 1,893 cases distributed in New Hampshire, Pennsylvania, and Florida.
Product
Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a cardboard box
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0703-2016·2016-02-10
Philips Allura Xper X-ray Systems Recalled for Image Display Error
Philips is recalling Allura Xper FD10/10 systems because a software issue may cause still images to be mistaken for live images during X-ray procedures.
Product
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2016·2016-02-10
Resmed Recalls Astral 100 and 150 External Batteries Due to Start-Up Issue
Resmed Corporation is recalling Astral 100 and 150 external batteries because of a start-up issue. The recall affects 14,736 units distributed in the US and internationally.
Product
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery…
Category
Medical Device
Distribution
32 states
HighFDA (Food)·F-0521-2016·2016-02-10
Signature Breads Recalls Frozen French Dinner Rolls for Metal Fragments
Signature Breads is recalling 1,893 cases of frozen parbaked French dinner rolls due to potential metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.
Product
Signature Breads Frozen Parbaked French Dinner Rolls 22251; 280 Units - 1 OZ, NET WT. 17.5 LB (7.93 kg), in a cardboard box
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0721-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0716-2016·2016-02-10
Philips Allura Centron Medical Imaging System Recalled for Image Display Error
Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as live images during medical procedures.
Product
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0734-2016·2016-02-10
Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination
Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected bandages were distributed nationwide.
Product
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2016·2016-02-10
Radiometer AQURE System Recalled for Sample Type Design Error
Radiometer America Inc is recalling 375 AQURE Systems (Model 933-599) because a design error may leave the sample type field blank, potentially leading to misinterpretation of blood gas and immunoassay results.
Product
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0522-2016·2016-02-10
Signature Breads Recalls Frozen French Mini Baguettes Due to Metal Fragments
Signature Breads, Inc. is recalling 1,893 cases of frozen French mini baguettes because they may contain metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.
Product
Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box
Category
Food
Distribution
3 states
HighNHTSA·16V080000·2016-02-10
Thomas Built Buses Recall School Buses with Peeling Stop Arm Decals
Daimler Trucks North America is recalling 878 school buses because reflective decals on stop arms may peel off, reducing visibility and increasing crash risk.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER HDX, SAF-T-LINER C2
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·16V076000·2016-02-10
Ram ProMaster Vans Recalled for Electronic Stability Control Defect
Chrysler is recalling 2016 Ram ProMaster vans with 3.0L diesel engines because the Electronic Stability Control system may fail to reactivate after being disabled, increasing crash risk.
Product
RAM — RAM PROMASTER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2016·2016-02-10
Philips UNIQ and Allura Systems Recall for Image Interpretation Error
Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical procedures.
Product
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2016·2016-02-10
Philips Allura Xper FD20/10 Recalled for Image Display Error
Philips is recalling 13,297 Allura Xper FD20/10 systems because a software error may cause still images to be interpreted as live images.
Product
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0730-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V075000·2016-02-10
Toyota Recalls 2013-2016 Scion FR-S for Ignition Key Removal Defect
Toyota is recalling 2013-2016 Scion FR-S vehicles because the ignition key may be removed without the transmission in Park, increasing the risk of the vehicle rolling away.
Product
SCION — SCION FR-S
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0726-2016·2016-02-10
Philips INTEGRIS Allura 9 Biplane Recalled for Image Interpretation Risk
Philips is recalling INTEGRIS Allura 9 Biplane systems because still images may be misinterpreted as live images, posing a risk to patient safety.
Product
INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2016·2016-02-10
Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error
Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.
Product
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0704-2016·2016-02-10
Philips Allura Xper OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular procedures.
Product
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0696-2016·2016-02-10
Global Healthcare Recalls ET-20 Anesthesia Extension Tubes Due to Kinking
Global Healthcare Inc. is recalling 2,000 cases of ET-20 Anesthesia Extension Tubes distributed in Georgia due to potential kinking that may pose a health hazard.
Product
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0747-2016·2016-02-10
Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation
The Anspach Effort, Inc. is recalling 599 Synthes Small Electric Drive units because they may malfunction, fail to operate, or start unintentionally.
Product
Synthes Small Electric Drive (SED). For use in general traumatology.
Category
Medical Device
Distribution
Distributed nationwide