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

25376–25400 of 27722

SevereFDA (Devices)·Z-1109-2014·2014-03-05
Philips HeartStart XL Defibrillators Recalled for Power Board Failure
Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.
Product
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0962-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0960-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1091-2014·2014-03-05
Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw
Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.
Product
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1048-2014·2014-03-05
Medline Recalls Heart Catheter Kits Due to Coating Defect
Medline Industries is recalling 160 Heart Cath Custom Packs because a guidewire component may have a flaking coating.
Product
HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1074-2014·2014-03-05
Philips BrightView Gamma Cameras Recalled for Patient Contact Risk
Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.
Product
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1054-2014·2014-03-05
Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling five surgical kits containing a guidewire with a potential coating flake-off defect.
Product
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1102-2014·2014-03-05
Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.
Product
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1051-2014·2014-03-05
Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect
Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking defect.
Product
CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0958-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1049-2014·2014-03-05
Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect
Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.
Product
CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0955-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1053-2014·2014-03-05
Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect
Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.
Product
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1089-2014·2014-03-05
Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk
Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.
Product
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1072-2014·2014-03-05
GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings
GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1055-2014·2014-03-05
Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect
Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.
Product
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1056-2014·2014-03-05
Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling 112 surgical kits containing guidewires with a potential for coating to flake off.
Product
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1047-2014·2014-03-05
Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect
Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.
Product
ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0953-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0959-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0961-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising airway maintenance.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1070-2014·2014-03-05
GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1105-2014·2014-03-05
Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk
Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.
Product
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1077-2014·2014-03-05
DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1052-2014·2014-03-05
Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires
Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.
Product
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
Category
Medical Device
Distribution
Distributed nationwide

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25376–25400 of 27722