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

4926–4950 of 5115

SevereFDA (Devices)·Z-0543-2013·2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 346 units of Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0539-2013·2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0557-2013·2012-12-26
ThyssenKrupp LEVANT Stairlifts Recalled Due to Seat Breakage Risk
ThyssenKrupp Access Corp is recalling 5,413 LEVANT stairlifts because the seat could break if the seat belt is trapped underneath the foldable part.
Product
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0574-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0541-2013·2012-12-26
Zimmer Persona Knee System Recalled for Tibial Perforation Risk
Zimmer, Inc. is recalling Persona knee system tibia implants and tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0550-2013·2012-12-26
Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk
Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0554-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0549-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Broach and Related Tools
Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and related tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0552-2013·2012-12-26
Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0514-2013·2012-12-26
Bunnell Patient Circuits Recalled Due to Heater Wire Insulation Melting
Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator because heater wire insulation can melt, causing sparking and smoke.
Product
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0542-2013·2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0553-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0544-2013·2012-12-26
Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
Zimmer, Inc. is recalling 195 Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0496-2013·2012-12-19
Medtronic SynchroMed EL Pumps Recalled Due to Unapproved Drug Interactions
Medtronic is recalling SynchroMed EL implantable infusion pumps because using unapproved drugs can cause the pump to stop working, halting drug delivery.
Product
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated fo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0497-2013·2012-12-19
Medtronic SynchroMed II Pumps Recalled for Motor Stall Risk
Medtronic is recalling SynchroMed II pumps because unapproved drugs can cause motor stalls and stop drug delivery.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the Sy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0467-2013·2012-12-12
iwalk BiOM Battery and Charger Recalled for Overheating and Smoke Risk
iwalk inc is recalling BiOM lower leg system batteries and chargers because they may overheat and smoke during charging.
Product
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0161-2013·2012-12-05
Medpro Elastomeric Infusion Pump Recalled for Higher Flow Rate
First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps because they may deliver medication at a higher flow rate than specified, risking over-administration.
Product
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0438-2013·2012-12-05
Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.
Product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-0435-2013·2012-12-05
Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality
Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.
Product
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0436-2013·2012-12-05
Terumo Advanced Perfusion System 1 Recalled for Power Loss
Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.
Product
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0439-2013·2012-12-05
Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion
Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.
Product
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surg
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2013·2012-11-28
NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0361-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0367-2013·2012-11-28
NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk
NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.
Product
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0371-2013·2012-11-28
NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide

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4926–4950 of 5115