Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

31126–31150 of 40449

ModerateFDA (Devices)·Z-0795-2016·2016-02-17
PharmaCaribe PulmoSal 7% Sodium Chloride Inhalation Solution Recalled for Mislabeling
Pharmacaribe LLC is recalling PulmoSal 7% Sodium Chloride inhalation solution because vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+).
Product
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0794-2016·2016-02-17
Merge Healthcare Recalls RadSuite Picture Archive System for Measurement Errors
Merge Healthcare is recalling RadSuite picture archive systems because they may display incorrect Standardized Uptake Values (SUV). The recall covers 164 units distributed nationwide.
Product
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0780-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific Trabecular Metal dental implants because safety information was omitted from the instructions for use.
Product
IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0776-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific dental implants because safety information was omitted from the instructions for use.
Product
IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0775-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Instructions in Manual
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because critical safety information was missing from the instruction manual.
Product
IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0758-2016·2016-02-17
Spectranetics Recalls Expired 2.3mm Turbo-Power Laser Atherectomy Catheters
Spectranetics Corp. is recalling 8 units of 2.3mm Turbo-Power OTW Manual laser atherectomy catheters because they are past their expiration date.
Product
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0779-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the latest instructions for use.
Product
IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0786-2016·2016-02-17
Bard Distaflo Vascular Bypass Graft Recalled for Size Mislabeling
Bard Peripheral Vascular Inc is recalling four units of the Bard Distaflo Vascular Bypass Graft because the product is mislabeled as 6 mm when it is actually 8 mm.
Product
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0784-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific dental implants because safety information was missing from the instructions for use.
Product
IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0782-2016·2016-02-17
Zimmer Dental Implants Recalled for Missing Instructions in Manual
Zimmer Dental Inc is recalling specific Trabecular Metal implants because the latest instruction manual omitted critical safety information for certain sizes.
Product
IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0777-2016·2016-02-17
Zimmer Dental Implants Recalled for Omitted Instructions
Zimmer Dental Inc. is recalling specific dental implants because important safety information was missing from the latest instruction manual.
Product
IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0691-2016·2016-02-10
Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction
Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.
Product
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0692-2016·2016-02-10
Draeger Oxylog 3000 Ventilators Recalled for Software Error
Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.
Product
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0745-2016·2016-02-10
Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors
Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.
Product
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2016·2016-02-10
Philips Allura Xper OR Table Recall for Image Interpretation Risk
Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 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 (Devices)·Z-0720-2016·2016-02-10
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 misinterpreted as live images.
Product
INTEGRIS BH3000; Model Number: 72242 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-0707-2016·2016-02-10
Philips Allura Xper FD20 Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20; Model Numbers: 722028 722012 722006 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 (Devices)·Z-0756-2016·2016-02-10
BioMerieux Recalls API ZYM Bx2 Reagent Due to False Negative Results
BioMerieux SA is recalling API ZYM Bx2 reagent because it produces false negative results, leading to discrepant identification outcomes in laboratory tests.
Product
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0735-2016·2016-02-10
MediChoice Cohesive Bandages Recalled for Microbial Contamination
Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination.
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-0712-2016·2016-02-10
Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 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 (Devices)·Z-0718-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.
Product
INTEGRIS HM3000; Model Number: 72239 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-0715-2016·2016-02-10
Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error
Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.
Product
Allura CV20; Model Number: 722031 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 maximum weight of 250…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2016·2016-02-10
Philips Allura Xper OR Table Recalled for Image Interpretation Error
Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20/20 OR Table; Model Number: 722039 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 (Devices)·Z-0706-2016·2016-02-10
Philips Allura Xper FD20/15 Recall for Image Display Error
Philips is recalling 13,297 Allura Xper FD20/15 systems worldwide because a software error may cause still images to be interpreted as live images.
Product
Allura Xper FD20/15; Model Numbers: 722058 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-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

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31126–31150 of 40449