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

37026–37050 of 40449

HighFDA (Devices)·Z-0418-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2014·2013-12-04
DePuy Recalls Knee Instruments Due to Potential Tab Fracture
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs may fracture and remain in patients.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2014·2013-12-04
Synthes Implant Holder Recalled Due to Breakage During Orthopedic Surgery
Synthes USA HQ, Inc. is recalling 548 Synfix (TM)-LR Implant Holders because they may break at the interface between the implant and the holder.
Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2014·2013-12-04
Synthes Matrix Coronal Bender Recall Due to Tip Breakage
Synthes USA is recalling 209 Matrix 5.5mm Coronal Benders because tips broke during use. The devices are used for spinal stabilization.
Product
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0374-2014·2013-12-04
Siemens Fluoroscopic X-Ray Systems Recalled for Radiation Malfunction
Siemens is recalling specific fluoroscopic x-ray systems due to a software defect that may cause radiation to continue longer than required, resulting in overexposed images.
Product
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0381-2014·2013-12-04
Biomet Recalls Oversized Security Blades for Carpal Tunnel Surgery
Biomet, Inc. is recalling 1,130 Security Blades for carpal tunnel surgery because they were manufactured oversized and may be difficult to advance through the mating clip.
Product
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2014·2013-12-04
Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening
Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0408-2014·2013-12-04
Synthes Slipped Capital Femoral Epiphysis System Recalled for Drill Bit Breakage
Synthes USA is recalling 166 units of the Slipped Capital Femoral Epiphysis System because guide wires may stick and drill bits may break during surgery.
Product
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0410-2014·2013-12-04
Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies
Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.
Product
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0392-2014·2013-12-04
Baxter Recalls VIAL-MATE Adaptors Due to Incomplete Foil Seal
Baxter Healthcare is recalling 38,400 units of VIAL-MATE Adaptors because an incomplete foil seal may compromise sterility.
Product
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0399-2014·2013-12-04
Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies
Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.
Product
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0401-2014·2013-12-04
Synthes 4.5mm Condylar Plate Recalled for Restricted Sales Release
Synthes USA is recalling a specific lot of 4.5mm condylar plates that were inadvertently released to a sales consultant restricted for sale.
Product
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0409-2014·2013-12-04
Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling
Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's part number.
Product
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0378-2014·2013-12-04
Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration
Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.
Product
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0377-2014·2013-12-04
Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration
Mizuho America is recalling 32 units of Sugita Titanium Standard Aneurysm Clip II due to discoloration. The devices are intended for single use in cerebral aneurysms.
Product
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0403-2014·2013-12-04
Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems
Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.
Product
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0404-2014·2013-12-04
Synthes 14.5 mm Outer Protection Sleeve Recalled for Incorrect Size
Synthes (USA) Products LLC is recalling 55 units of 14.5 mm Outer Protection Sleeves that were incorrectly packaged as 12.0 mm units.
Product
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0380-2014·2013-12-04
Synthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling
Synthes USA is recalling 98 units of 2.4 and 2.7 mm Locking Screws because 2.7 mm screws were incorrectly labeled as 2.4 mm.
Product
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0394-2014·2013-12-04
Synthes Spiked Washers Recalled Due to Mislabeled Size
Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.
Product
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0400-2014·2013-12-04
Lanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect
Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short because the tip is oversized.
Product
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0398-2014·2013-12-04
Medtronic Recalls Delta Shunt Assembly Kits Due to Label Discrepancies
Medtronic Neurosurgery is recalling Delta Shunt Assembly Kits because label discrepancies were found. The recall covers 34 units distributed worldwide.
Product
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0384-2014·2013-12-04
Synthes Matrix Threaded Persuader Recalled Due to Reduction Insert Breakage
Synthes USA HQ, Inc. is recalling 634 units of the Matrix Threaded Persuader because the Reduction Insert can break during use, preventing the instrument from functioning.
Product
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
Category
Medical Device
Distribution
Distributed nationwide

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37026–37050 of 40449