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 deaths or serious injuries are reported, 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

4301–4325 of 5111

SevereFDA (Devices)·Z-0904-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.
Product
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0903-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.
Product
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2015·2015-01-14
Trumpf Medical Systems Recalls JUPITER U Remote Controls for Unintended Movement
Trumpf Medical Systems is recalling JUPITER U remote controls because damaged units may cause unintended movement of operating tables during surgery.
Product
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sys
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-0896-2015·2015-01-07
Hansen Medical Recalls Sensei X Robotic Catheter Systems Due to Loose Clamp
Hansen Medical is recalling Sensei X Robotic Catheter Systems because a mechanical clamp may become loose, causing the device to fall and potentially injure patients or users.
Product
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to f
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0889-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0583-2015·2014-12-31
Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2015·2014-12-31
Invacare PerfectO2 Oxygen Concentrator Capacitor Recall for Fire Hazard
Invacare is recalling Dianz Capacitors used in PerfectO2 Oxygen Concentrators because they may rupture and cause a fire.
Product
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0848-2015·2014-12-31
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2015·2014-12-31
Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0824-2015·2014-12-24
Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk
Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.
Product
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0507-2015·2014-12-17
TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure
TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.
Product
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
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
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-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 infusi
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
CriticalFDA (Devices)·Z-0454-2015·2014-12-10
ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure
ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposab
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0462-2015·2014-12-10
ConMed Multifunction Electrodes Recalled for Connection Design Failure
ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.
Product
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0461-2015·2014-12-10
ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws
ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.
Product
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposa
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0460-2015·2014-12-10
ConMed Pediatric Electrodes Recalled Due to Connection Design Changes
ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.
Product
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0383-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0311-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0457-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0455-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0296-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.
Product
Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states

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4301–4325 of 5111