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

32551–32575 of 40449

HighFDA (Devices)·Z-2135-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling specific software versions for its s5 and CORE Intravascular Ultrasound Systems because they may calculate inaccurate FFR/iFR values under certain circumstances.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2015·2015-07-29
Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2200-2015·2015-07-29
Philips Pinnacle3 Radiation Treatment Planning Software Recalled for Dose Inconsistency
Philips is recalling Pinnacle3 Radiation Treatment Planning System software versions 8.0 and 9.0 due to potential dose inconsistencies with density-overridden ROIs.
Product
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2177-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2015·2015-07-29
ArthroCare Plasma Wand Devices Recalled for Dielectric Specification Failures
ArthroCare Corporation is recalling 733 EVac 70 XTRA and PROcise EZ View plasma wand devices because they were released without meeting dielectric specifications.
Product
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2015·2015-07-29
American Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure
American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.
Product
American Catheter / Cholangiogram Catheter 9100 Series.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2193-2015·2015-07-29
Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects
Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.
Product
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling two WIZARD2 gamma counters due to a barcode label error that may produce erroneous results.
Product
Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2015·2015-07-29
GE Healthcare Precision MPi Fluoroscopic Imaging Systems Recalled for Monitor Fall Risk
GE Healthcare is recalling Precision MPi fluoroscopic imaging systems because a monitor fell from its suspension, posing a risk of injury to patients or operators.
Product
GE Healthcare, Precision MPi fluoroscopic imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2119-2015·2015-07-29
FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise
The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.
Product
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Disassociation Risk
DePuy Orthopaedics is recalling ATTUNE RP CR Articulation Surface trial instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2140-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient.
Product
ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2166-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2015·2015-07-29
Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.
Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2118-2015·2015-07-29
FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise
FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.
Product
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2160-2015·2015-07-29
FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2163-2015·2015-07-29
FDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues
American Medical Systems is recalling 16,710 Sure F!ex laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2151-2015·2015-07-29
Gardner Denver Thomas Recalls Medi-Pump Aspirators Due to Performance Issues
Gardner Denver Thomas is recalling 508 Medi-Pump aspirators because the vacuum pump may not perform to specification.
Product
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2172-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2098-2015·2015-07-29
CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error
CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.
Product
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2169-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2148-2015·2015-07-29
EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure
EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.
Product
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is…
Category
Medical Device
Distribution
Distributed nationwide

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32551–32575 of 40449