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

23151–23175 of 27699

SevereFDA (Devices)·Z-2136-2015·2015-07-29
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 calculate inaccurate FFR/iFR values.
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 CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2116-2015·2015-07-29
FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves
The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.
Product
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2107-2015·2015-07-29
FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2015·2015-07-29
FDA Recalls Sterile Single Basin Kits with Compromised Gloves
The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.
Product
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2015·2015-07-29
Recall of Sterile Major Kits with Defective Devon Light Gloves
FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.
Product
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2015·2015-07-29
Biomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength
Biomet Spine is recalling 4,765 units of Polaris 4.75 TI Spinal System multiaxial screws because they may not meet internal fatigue strength requirements.
Product
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2139-2015·2015-07-29
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 during surgery.
Product
ATTUNE RP PS 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-2154-2015·2015-07-29
Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage
Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.
Product
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2015·2015-07-29
FDA Recalls Devon Light Gloves for Sterility Compromising Defects
The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.
Product
Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2015·2015-07-29
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, 18S, 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-2162-2015·2015-07-29
FDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sure F!ex reusable laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
200¿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
HighFDA (Devices)·Z-2134-2015·2015-07-29
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 software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i 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-2122-2015·2015-07-29
GE Healthcare Precision RXi Digital System Monitor Suspension Recall
GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk to patients or operators.
Product
GE Healthcare Precision RXi Digital system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2015·2015-07-29
FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes
The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.
Product
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
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 s5x. 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-2188-2015·2015-07-29
Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.
Product
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2102-2015·2015-07-29
Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk
Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.
Product
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2097-2015·2015-07-29
Maquet Magnus Hybrid OR Table Column Recalled for Collision Risk
Maquet is recalling 12 Magnus Hybrid OR Table Columns due to a potential collision risk with the C-arm of the Siemens Artis Zeego Angiography System.
Product
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2015·2015-07-29
Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects
Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.
Product
GEMINI TF Big Bore 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-2133-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling Volcano 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 software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. 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-2178-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning 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, 18S, 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
HighFDA (Devices)·Z-2176-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Stripper Tools Due to Sterilization Issues
American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.
Product
Tool, Stripper W/BLD, 14S, 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
HighFDA (Devices)·Z-2153-2015·2015-07-29
Bausch & Lomb SofPort Advanced Optics Aspheric Lens Recall for Haptic Breakage
Bausch & Lomb is recalling SofPort Advanced Optics Aspheric Lenses because haptics may break during loading and insertion.
Product
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2015·2015-07-29
Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk
Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.
Product
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1838-2015·2015-07-29
Hitachi PROBEAT Proton Beam System Recalled for Radiation Delivery Issues
Hitachi America is recalling three PROBEAT proton beam systems due to potential radiation delivery inconsistencies during system reboots.
Product
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
1 state

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23151–23175 of 27699