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

31651–31675 of 40325

HighFDA (Devices)·Z-0157-2016·2015-10-28
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach compromised the device's sterility.
Product
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2016·2015-10-28
Cardinal Health Recalls Ambitex NMD400 Nitrile Exam Gloves Due to Leak Test Failure
Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves (size medium) because samples failed FDA water leak tests, compromising their barrier function.
Product
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0154-2016·2015-10-28
Berchtold TELETOM Equipment Management System Recall for Control Malfunction
Berchtold Corp. is recalling TELETOM Equipment Management Systems 4 and 6 series due to potential control and brake failure caused by fluid intrusion.
Product
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2016·2015-10-28
Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems because a breach in the packaging compromised the device's sterility.
Product
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0131-2016·2015-10-28
Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues
Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.
Product
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0143-2016·2015-10-28
ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental Knee Replacement System because they may contain small amounts of ethylene glycol residue.
Product
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0152-2016·2015-10-28
Smiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling
Smiths Medical ASD, Inc. is recalling Port-A-Cath Plastic Hub Needles from Lot 46262 because the lid stock labels contain incorrect part numbers, descriptions, and images.
Product
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0147-2016·2015-10-28
ConFormis iTotal Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS is recalling 110 units of the iTotal Posterior Stabilized Knee Replacement System because they may contain small amounts of ethylene glycol residue.
Product
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0137-2016·2015-10-28
Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty
Biomet Microfixation is recalling 5 Thinflap System Cases because the lids require excessive force to open.
Product
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0134-2016·2015-10-28
Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error
Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.
Product
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0144-2016·2015-10-28
ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 3 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.
Product
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0150-2016·2015-10-28
B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration
B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.
Product
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0146-2016·2015-10-28
ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.
Product
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0153-2016·2015-10-28
OneTray Sealed Sterilization Containers Recalled for Incorrect Labeling
Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers because the labels list the wrong steam sterilization time.
Product
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0149-2016·2015-10-28
Natus neoBLUE 3 Phototherapy System Recalled for Intensity Documentation
Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.
Product
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0136-2016·2015-10-28
Biomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled
Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.
Product
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0135-2016·2015-10-28
Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging
Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.
Product
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the…
Category
Medical Device
Distribution
22 states
ModerateFDA (Devices)·Z-0140-2016·2015-10-28
ConForMIS iUNI Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential ethylene glycol residue.
Product
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0139-2016·2015-10-28
ConForMIS Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial due to potential small amounts of ethylene glycol residue.
Product
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0125-2016·2015-10-21
Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.
Product
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2016·2015-10-21
ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement
ViewRay is recalling four MRIdian Radiation Therapy Systems because the patient couch may move unexpectedly if an encoder fails and the system is restarted.
Product
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0119-2016·2015-10-21
Zimmer Natural Nail CM Long Intramedullary Fixation Rods Recalled for Packaging Defects
Zimmer GmbH is recalling 57,603 units of Natural Nail CM Long intramedullary fixation rods because compromised outer trays may lead to periprosthetic infection.
Product
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2016·2015-10-21
DJO Monode Shortwave Accessory Recalled for Overheating and Burning Insulation
DJO, LLC is recalling Monode Shortwave Accessories due to overheating and burning of the wire insulation inside the applicator.
Product
Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0123-2016·2015-10-21
Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.
Product
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2016·2015-10-21
Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 Pipeline and Pipeline Flex Embolization Devices because they were shipped with EU-version Instructions for Use.
Product
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided…
Category
Medical Device
Distribution
9 states

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31651–31675 of 40325