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

24001–24025 of 27699

SevereFDA (Devices)·Z-0562-2015·2014-12-17
PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.
Product
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0523-2015·2014-12-17
Siemens Mammomat Inspiration System Recalled for Potential Instability
Siemens is recalling three Mammomat Inspiration systems because the workstation table may fall over if not secured, posing a risk of serious injury.
Product
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0590-2015·2014-12-17
Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper
Smith & Nephew is recalling 45 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0524-2015·2014-12-17
Medtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk
Medtronic MiniMed is recalling Silhouette and Sure-T infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0591-2015·2014-12-17
Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper
Smith & Nephew is recalling 23 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0576-2015·2014-12-17
Siemens Medical Solutions Recalls Syngo.plaza PACS Software for Print Size Errors
Siemens Medical Solutions is recalling 149 units of Syngo.plaza and syngo Imaging XS software because printouts may be in incorrect anatomical size, potentially influencing diagnostic decisions.
Product
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2015·2014-12-17
BD Insyte Autoguard Catheter Recall for Potential Body Damage
Becton Dickinson is recalling BD Insyte Autoguard catheters due to potential damage along the catheter body.
Product
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0566-2015·2014-12-17
PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays
PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they may exceed USP limits for bacterial endotoxin.
Product
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0580-2015·2014-12-17
Boston Scientific Recalls IntellaMap Orion Mapping Catheters Due to Glue Failure
Boston Scientific is recalling 184 IntellaMap Orion High Resolution Mapping Catheters because a glue bond on the Deployment Interlock Button may fail.
Product
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0588-2015·2014-12-17
Mevion S250 Proton Therapy System Recalled for Software Defect
Mevion Medical Systems is recalling one MEVION S250 proton therapy system in Missouri due to a software defect that may cause incorrect dose delivery.
Product
MEVION S250, used for proton radiation therapy.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0575-2015·2014-12-17
INOmax DSIR Nitric Oxide System Recalled for Monitoring Error
INO Therapeutics is recalling nine INOmax DSIR Nitric Oxide delivery systems because they may report lower-than-expected NO concentrations.
Product
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0564-2015·2014-12-17
PFM Medical Recalls Dual Lumen CT PICC Catheters for Bacterial Endotoxin
PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters because they may exceed USP limits for bacterial endotoxin.
Product
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2015·2014-12-17
Invacare Perfecto 2 V Oxygen Concentrator Recalled for Defective Sieve Beds
Invacare is recalling 5,963 Perfecto 2 V Oxygen Concentrators because defective sieve beds allow dust to migrate, reducing oxygen concentration.
Product
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0582-2015·2014-12-17
Skeletal Dynamics Recalls Align Radial Stems Due to Fracture Reports
Skeletal Dynamics is recalling 1,700 Align Radial Stems because a report was received indicating the device fractured.
Product
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0568-2015·2014-12-17
PFM Medical Recalls ASEPT Drainage Bags Due to Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 2000 ml Drainage Bags because they may exceed USP limits for bacterial endotoxin. The recall affects 370 units distributed in the US and internationally.
Product
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2015·2014-12-17
Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin
Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 units distributed in the US and abroad.
Product
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2015·2014-12-17
Medtronic Recalls Affinity Fusion Oxygenators Due to Damaged Heat Exchangers
Medtronic Perfusion Systems is recalling 168 Affinity Fusion Oxygenators with Carmeda Bioactive Surface due to damaged heat exchangers.
Product
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0589-2015·2014-12-17
Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper
Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0530-2015·2014-12-17
Abbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect
Abbott Medical Optics is recalling Healon EndoCoat ophthalmic devices because the finger grip can dislodge, potentially causing eye trauma during surgery.
Product
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2015·2014-12-17
Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.
Product
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2015·2014-12-17
Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization
Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.
Product
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2015·2014-12-17
Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.
Product
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2015·2014-12-17
PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin
PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.
Product
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0563-2015·2014-12-17
PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits
PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.
Product
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous…
Category
Medical Device
Distribution
Distributed nationwide

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24001–24025 of 27699