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

25726–25750 of 40357

HighFDA (Devices)·Z-3235-2017·2017-10-04
Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes
Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.
Product
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3149-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk
Zimmer Biomet is recalling 171 orthopedic surgical instruments because raw material anomalies may increase the risk of instrument fracture during use.
Product
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3166-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 3,232 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3174-2017·2017-10-04
Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 173 nonsterile straight shank drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3172-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 356 ECT Internal Fracture Fixation Drills because a raw material anomaly may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3232-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3173-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 389 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 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3177-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 217 nonsterile ECT Internal Fracture Fixation Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture.
Product
ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2017·2017-10-04
Teleflex Percuvance Scissors Tool Tip Recall for Connection and Jaw Issues
Teleflex Medical is recalling Percuvance Scissors Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.
Product
Percuvance Scissors 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 soft…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-3152-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 155 orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.
Product
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3230-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3155-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 224 sterile M/DN Intramedullary Fixation Distal Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3186-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 240 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 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3209-2017·2017-10-04
Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions
Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.
Product
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3216-2017·2017-10-04
Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error
Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Product
Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3226-2017·2017-10-04
Bard Magic 3 Antibacterial Catheters Recalled for Missing Coating
C.R. Bard is recalling specific lots of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheters because they may lack the hydrophilic coating.
Product
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-3212-2017·2017-10-04
Teleflex Recalls LMA MADgic Devices Due to Labeling Deficiencies
Teleflex Medical is recalling LMA MADgic devices because package labels may contain missing or incomplete information.
Product
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3217-2017·2017-10-04
Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error
Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Product
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3214-2017·2017-10-04
Ultradent Paper Points Recalled for Sterile Barrier Labeling Error
Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.
Product
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3227-2017·2017-10-04
Medtronic Heli-FX Guide Catheter Recalled for Labeling Mismatch
Medtronic is recalling 20 units of the Heli-FX Guide 42 mm catheter because the deflection length on the handle does not match the box label.
Product
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-3211-2017·2017-10-04
Deerfield Imaging Recalls Starburst Adaptor Thumb Screws Due to Incorrect Thread
Deerfield Imaging is recalling six Starburst adaptor thumb screws because they have incorrect threads. The affected units were distributed in Illinois, Oregon, and Pennsylvania.
Product
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-3218-2017·2017-10-04
Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error
Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterility.
Product
Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3215-2017·2017-10-04
Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement
Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.
Product
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3213-2017·2017-10-04
Smiths Medical Recalls UniPerc Tracheostomy Tube Kits with Incorrect Obturator Size
Smiths Medical is recalling 89 UniPerc tracheostomy tube kits because they contain a 9.0mm obturator instead of the correct 8.0mm size.
Product
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-3208-2017·2017-10-04
Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions
Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.
Product
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S…
Category
Medical Device
Distribution
0 states

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25726–25750 of 40357