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.

30726–30750 of 50502

HighFDA (Devices)·Z-3229-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group Italia SRL is recalling Platinium DR 1510 ICDs due to a possibility of overconsumption following ElectroStatic Discharge (ESD) during implant surgery or MRI scans.
Product
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3195-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3165-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 3,640 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3145-2017·2017-10-04
Zimmer Biomet Recalls Herbert Cannulated Bone Screw System Drills
Zimmer Biomet is recalling 18 units of Herbert Cannulated Bone Screw System drills due to raw material anomalies that may increase the risk of instrument fracture.
Product
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3159-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Pilot Tips Due to Fracture Risk
Zimmer Biomet is recalling 27 nonsterile orthopedic drill pilot tips because raw material anomalies may increase the risk of instrument fracture during use.
Product
M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·18003·2017-10-04
Suunto Recalls Wireless Tank Transmitters Due to Bursting Hazard
Suunto is recalling approximately 35,500 Wireless Tank Transmitters and Tank PODs because the exterior plastic case can burst during pre-dive pressure testing, posing an injury hazard.
Product
Wireless Tank Transmitter and Tank POD
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3168-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 1,250 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3169-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 1,286 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3222-2017·2017-10-04
Teleflex Percuvance Maryland Dissector Tool Tip Recall for Connection Issues
Teleflex Medical is recalling Percuvance Maryland Dissector Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.
Product
Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips…
Category
Medical Device
Distribution
29 states
HighFDA (Food)·F-3574-2017·2017-10-04
Rajbhog Jalebi Recalled for Undeclared Almond Allergen
Rajbhog Distributors is recalling 1,467 packets of Jalebi sweet due to an undeclared almond allergen. The product was distributed in seven southeastern states.
Product
Rajbhog Sweet, JALEBI, Net Weight 11.2 oz. (315 grams), Distributed by Rajbhog Distributors (GA) Inc., Duluth, GA 30096.
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3236-2017·2017-10-04
Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach
Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is used to cover surgical equipment, not patients.
Product
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3190-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 30 units of orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.
Product
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3144-2017·2017-10-04
Zimmer Biomet Recalls Sterile Shoulder System Drills Due to Fracture Risk
Zimmer Biomet is recalling 2,825 sterile shoulder system drills manufactured with raw material anomalies that may increase the risk of instrument fracture.
Product
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3234-2017·2017-10-04
Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach
Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is intended for equipment coverage, not patient contact.
Product
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic surgical drills and screw taps because raw material anomalies may cause the instruments to fracture during use.
Product
Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3219-2017·2017-10-04
Teleflex Percuvance Gripper Grasper Tool Tip Recall for Connection Issues
Teleflex Medical is recalling 20,039 Percuvance Gripper Grasper Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.
Product
Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-3189-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 62 units of the Natural Nail System Calibrated Drill Short 4.9 mm because raw material anomalies may increase the risk of instrument fracture during use.
Product
Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3197-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Material Anomaly
Zimmer Biomet is recalling 236 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3184-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills
Zimmer Biomet is recalling 412 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3185-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 198 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.
Product
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3203-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 75 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3225-2017·2017-10-04
Fujifilm Recalls 362 Fujinon ED-530XT Endoscopes for Reprocessing Risk
Fujifilm Medical Systems is recalling 362 Fujinon ED-530XT endoscopes nationwide to reduce patient risk from inadequate reprocessing.
Product
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause instrument fracture during use.
Product
Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3146-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
Zimmer Biomet is recalling 2 units of Long Drill 1/4 inch orthopedic surgical instruments due to raw material anomalies that may increase the risk of instrument fracture.
Product
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3163-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 1,558 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide