Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

42376–42400 of 50511

HighFDA (Food)·F-0353-2014·2013-12-04
Plum Organics Baby Food Recalled for Post-Process Contamination
Plum Inc is recalling Sweet Potato, Mango & Millet Organic Baby Food due to a manufacturing defect that led to post-process contamination.
Product
Plum Organics Sweet Potato, Mango & Millet Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0369-2014·2013-12-04
Plum Kids Beetbox Berry Fruit and Veggie Mashups Recalled for Contamination
Plum Inc is recalling specific lots of Plum Kids Beetbox Berry Fruit and Veggie Mashups due to a manufacturing defect that led to post-process contamination.
Product
Plum Kids Beetbox Berry Fruit and Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
Category
Food
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
HighCPSC·14039·2013-12-04
Manhattan Toy Quixel Baby Rattles Recalled for Choking Hazard
Manhattan Group is recalling Quixel baby rattles because the arches can break, creating small parts that pose a choking hazard to young children.
Product
Manhattan Toy® Quixel™ baby rattles
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·14040·2013-12-04
Wearever Girl's Hooded Jacket Sets Recalled for Strangulation Hazard
David's Place is recalling Wearever Girl's hooded jacket and pant sets because the hood drawstrings pose a strangulation hazard to young children.
Product
Girl's long sleeve hooded jacket and pant sets
Category
Consumer Product
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
HighCPSC·14037·2013-12-04
K2 Revo Kick Kickboards Recalled for Handle Detachment Hazard
K2 Sports is recalling K2 Revo Kick kickboards/scooters because the front assembly can break, causing the handle to detach and posing a fall hazard to riders.
Product
K2 Revo Kick kickboards/scooters
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0375-2014·2013-12-04
Plum Organics Baby Food Recalled for Post-Process Contamination
Plum Inc is recalling Kale, Apple & Greek Yogurt baby food pouches due to a manufacturing defect causing post-process contamination.
Product
Plum Organics Kale, Apple & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0350-2014·2013-12-04
MRM Recalls Gluten Free 60 vcaps Due to Chloramphenicol Contamination
Metabolic Response Modifier is recalling Gluten Free 60 vcaps because the product may contain trace amounts of the antibiotic chloramphenicol.
Product
Gluten Free 60 vcaps, sku#609492310194. 12 units per shipping carton/case.
Category
Food
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 (Food)·F-0391-2014·2013-12-04
Las Trojes Recalls Coconut Brittle for Undeclared Soy Lecithin
Las Trojes is recalling specific lots of Coconut Brittle because they may contain undeclared soy lecithin, a common allergen.
Product
Coconut Brittle ("Pepitoria De Coco"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00013 3.
Category
Food
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
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 (Food)·F-0377-2014·2013-12-04
Plum Inc Recalls Parsnip, Blueberry & Buckwheat Pouches for Contamination
Plum Inc is recalling Parsnip, Blueberry & Buckwheat pouches due to a manufacturing defect that led to post-process contamination.
Product
Parsnip, Blueberry & Buckwheat Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA…
Category
Food
Distribution
Distributed nationwide
HighNHTSA·13V608000·2013-12-04
Triumph Recalls 2013 Trophy SE Motorcycles Due to Center Stand Defect
Triumph is recalling 416 model year 2013 Trophy SE motorcycles because the left-hand center stand mount may fracture, potentially causing the bike to fall over while parked.
Product
TRIUMPH — TRIUMPH TROPHY SE
Category
Vehicle
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 (Food)·F-0393-2014·2013-12-04
Las Trojes Peanut Brittle Recalled for Undeclared Soy Lecithin
Las Trojes is recalling peanut brittle products because they may contain undeclared soy lecithin, a potential allergen.
Product
Peanut Brittle ("Pepitoria De Cacahuate"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00012 6.
Category
Food
Distribution
1 state
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 (Food)·F-0361-2014·2013-12-04
Plum Organics Baby Food Recalled for Post-Process Contamination Risk
Plum Inc is recalling specific lots of Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food due to a manufacturing defect that could lead to post-process contamination.
Product
Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT.…
Category
Food
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 (Food)·F-0363-2014·2013-12-04
Plum Organics Baby Food Recalled for Manufacturing Defect
Plum Inc is recalling Spinach, Peas & Pear Organic Baby Food due to a manufacturing defect that led to post-process contamination.
Product
Plum Organics Spinach, Peas & Pear Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
Category
Food
Distribution
Distributed nationwide