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 deaths or serious injuries are reported, 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

4201–4225 of 5111

SevereFDA (Devices)·Z-2082-2015·2015-07-22
FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect
Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.
Product
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1951-2015·2015-07-15
Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties
FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.
Product
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2046-2015·2015-07-15
Biomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects
Biomet is recalling 75 A.L.P.S. Foot Locking Calcaneus Plates because thread defects may cause screws to back out or shear, potentially requiring revision surgery.
Product
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1989-2015·2015-07-15
Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides
Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.
Product
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1904-2015·2015-07-08
Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Product
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1894-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1954-2015·2015-07-08
ViewRay Treatment Planning Software Recalled for Location Calculation Failure
ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.
Product
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1873-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1888-2015·2015-07-08
Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1917-2015·2015-07-08
HeartWare Ventricular Assist System Recalled for Power Switching Issues
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
Product
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Category
Medical Device
Distribution
32 states
SevereFDA (Devices)·Z-1892-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1897-2015·2015-07-08
Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1836-2015·2015-07-01
Stryker Recalls Trocars Due to Reported Fracture at Distal Tip
Stryker is recalling specific cannula and seal models because they may fracture at the tip, leaving fragments at the surgical site.
Product
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1827-2015·2015-07-01
Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination
Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate due to bacterial contamination. The product is used in hemodialysis machines.
Product
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1834-2015·2015-07-01
Stryker Recalls Fios First Entry Trocars Due to Fracture Risk
Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.
Product
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proce
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1820-2015·2015-07-01
Hill-Rom Steriseal-Cannula Ophthalmic Recall Due to Dislodgement Risk
Hill-Rom is recalling Steriseal-Cannula Ophthalmic handpieces because the metal cannula can rotate and become dislodged from the plastic handpiece.
Product
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1831-2015·2015-07-01
Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
Stryker Endoscopy is recalling 22,063 SERFAS 90 degree Energy Probes because fragments of the probe have been reported to break off into patients during arthroscopic procedures.
Product
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the h
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1835-2015·2015-07-01
Stryker Recalls Optical Access Systems Due to Fracture Risk
Stryker is recalling specific Optical Access Systems because they may fracture at the tip, leaving fragments at the surgical site.
Product
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdomina
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1818-2015·2015-06-24
Hill-Rom Viking Mobile Patient Lifts Recalled for Potential Free Fall Hazard
Hill-Rom is recalling Viking M, L, and XL Mobile Lifts because a damaged actuator can cause the lift arm to drop suddenly, posing a risk of patient injury or death.
Product
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1731-2015·2015-06-24
HeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures
HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.
Product
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Category
Medical Device
Distribution
32 states
CriticalFDA (Devices)·Z-1706-2015·2015-06-17
Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.
Product
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Category
Medical Device
Distribution
12 states
CriticalFDA (Devices)·Z-1726-2015·2015-06-17
HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction
HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.
Product
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Category
Medical Device
Distribution
32 states
SevereFDA (Devices)·Z-1781-2015·2015-06-17
Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards
Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
Product
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Category
Medical Device
Distribution
Distributed nationwide

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4201–4225 of 5111