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

32476–32500 of 40325

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
ModerateFDA (Devices)·Z-2181-2015·2015-07-29
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 products.
Product
Tool, Stripper W/BLD, 44S, 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
ModerateFDA (Devices)·Z-2127-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error
Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.
Product
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2207-2015·2015-07-29
Siemens Recalls ADVIA Centaur Tni-Ultra Assay Due to System Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Tni-Ultra Assay kits due to system-to-system bias between different ADVIA Centaur platforms.
Product
ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2015·2015-07-29
Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints
Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.
Product
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2157-2015·2015-07-29
FDA Recalls Sureflex 200 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 200 Lithotripsy Fibers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.
Product
Sureflex 200 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-2184-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Stripper, 0.6mm Disposable EndoStat Fiber, 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-2205-2015·2015-07-29
Philips Recalls Head Holders Shipped with Ingenuity CT Systems
Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.
Product
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-2129-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error
Perkinelmer is recalling 18 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
Product
Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2204-2015·2015-07-29
Philips Recalls Head Holders for Ingenuity Core 128 CT Systems
Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.
Product
Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-2096-2015·2015-07-29
Safety PICC Insertion Tray Recalled for Incorrect Non-Sterile Packaging Item
Custom Healthcare Systems is recalling Safety PICC Insertion Trays because the outer packaging contains an incorrect non-sterile saline flush syringe.
Product
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2103-2015·2015-07-29
Allergan Recalls Natrelle Tissue Expanders Due to Expired Shelf Life
Allergan is recalling Natrelle 133 and CUI Series Tissue Expanders because the shipped products were beyond their 47-month shelf life.
Product
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2208-2015·2015-07-29
Silhouette Suture Brochure Recalled for Incomplete Risk Information
Silhouette Lift, Inc. is recalling Silhouette Suture brochures because they omit a complete list of risks and side effects, potentially misleading patients about product safety.
Product
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-2183-2015·2015-07-29
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 products.
Product
Tool, Stripper W/BLD, 28S, 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
ModerateFDA (Devices)·Z-2126-2015·2015-07-29
Perkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error
Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
Product
WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2015·2015-07-29
Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length
Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.
Product
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2171-2015·2015-07-29
FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2173-2015·2015-07-29
American Medical Systems 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 products.
Product
Tool, StripperW/BLD, 10S, 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

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32476–32500 of 40325