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

37001–37025 of 40449

ModerateFDA (Devices)·Z-0434-2014·2013-12-11
Advanced Sterilization Products Recalls SteriTite Containers Due to Sterility Assurance Concerns
Advanced Sterilization Products is recalling SteriTite containers because data does not consistently show that the required sterility assurance level is achieved during testing.
Product
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0443-2014·2013-12-11
Cincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10
Cincinnati Sub-Zero Products Inc is recalling 12 units of Blanketrol III Data Export Software Version 1.10 because the wrong software version was released to a customer.
Product
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0430-2014·2013-12-11
Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error
Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.
Product
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0429-2014·2013-12-11
Synthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
Synthes USA HQ, Inc. is recalling 374 units of the Small Extendible Soft Tissue Retractor due to a locking nut malfunction.
Product
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0448-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0450-2014·2013-12-11
CareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error
CareFusion is recalling 480 units of SmartSite Low Sorbing Infusion Sets because they were not assembled with low-sorbing tubing.
Product
SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0445-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 45 units of Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0421-2014·2013-12-04
DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
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 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
SevereFDA (Devices)·Z-0415-2014·2013-12-04
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 be left in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED 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
SevereFDA (Devices)·Z-0423-2014·2013-12-04
DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
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 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
SevereFDA (Devices)·Z-0417-2014·2013-12-04
DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
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 NONCEMENTED 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
SevereFDA (Devices)·Z-0413-2014·2013-12-04
DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
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 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-0385-2014·2013-12-04
Roche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters
Roche is recalling 6,595 ACCU-CHEK Aviva Combo Blood Glucose Meters due to a software issue that may cause incorrect insulin bolus advice.
Product
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2014·2013-12-04
Synthes Recalls 3.7mm and 5.0mm Dynamic Locking Screws Due to Breakage
Synthes USA HQ, Inc. is recalling 3.7mm and 5.0mm Dynamic Locking Screws because they may break at the distal tip during removal.
Product
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2014·2013-12-04
B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage
B. Braun Medical is recalling addEASE Binary Connectors because a misaligned needle may cause solution to leak from the PAB bag.
Product
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2014·2013-12-04
Siemens RAD Fluoro Uro System Recalled for Radiation Malfunction
Siemens is recalling 59 RAD Fluoro Uro systems because a software malfunction can cause radiation to continue longer than required, resulting in overexposed images.
Product
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0395-2014·2013-12-04
Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening
Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap loosening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 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-0425-2014·2013-12-04
B. Braun Recalls addEASE Binary Connectors Due to Solution Leakage
B. Braun Medical is recalling 4,000 addEASE Binary Connectors because a misaligned needle may cause solution to leak from the bag stopper.
Product
13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0416-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is 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 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
HighFDA (Devices)·Z-0389-2014·2013-12-04
Mindray Recalls V Series Patient Monitors Due to Power Pin Issue
Mindray is recalling V Series Patient Monitors because power pins may lose tension, causing the screen to go blank or shut down.
Product
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2014·2013-12-04
Custom Ultrasonics Endoscope Washer/Disinfector Recalled for Incomplete Validation
Custom Ultrasonics is recalling 118 System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector units because they were not fully validated prior to distribution.
Product
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2014·2013-12-04
Synthes 2.4 mm LC-DCP Plate Recalled Due to Foreign Object
Synthes (USA) Products LLC is recalling 13 units of 2.4 mm LC-DCP Plates because a screw was found in a package labeled for the plate.
Product
Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0414-2014·2013-12-04
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 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-0411-2014·2013-12-04
Biomet Recalls Shortened Plug Driver Due to Instrument Tip Shearing
Biomet is recalling two units of a Shortened Plug Driver after a complaint reported the instrument tip sheared off during a surgical removal case.
Product
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0388-2014·2013-12-04
Synthes Tensioning Device Recalled Due to Potential Mechanical Failure
Synthes USA HQ, Inc. is recalling 369 Tensioning Devices because the reaction fork may come loose, preventing the device from applying tension or releasing the wire.
Product
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue…
Category
Medical Device
Distribution
Distributed nationwide

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37001–37025 of 40449