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

21101–21125 of 40124

ModerateFDA (Devices)·Z-1004-2019·2019-03-20
Ossur LIL Angel Vest Recalled for Labeling and Safety Testing Issues
Ossur Americas is recalling 45 LIL Angel Vests because the titanium pin labels incorrectly list ceramic tips and require confirmatory safety testing.
Product
Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-1008-2019·2019-03-20
Olympus GIF-H180J Gastrointestinal Videoscope Recalled Due to Adhesive Error
Olympus is recalling one GIF-H180J videoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.
Product
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0997-2019·2019-03-20
Ossur Skull Pin Recall Due to Labeling Error and Safety Testing
Ossur Americas is recalling 372 sterile titanium skull pins because the label incorrectly lists a ceramic tip and the products require confirmatory safety testing.
Product
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-1002-2019·2019-03-20
Ossur J Tong Sterile Medical Device Recall for Labeling Error
Ossur Americas is recalling 138 units of J Tong sterile medical devices because the titanium pin label incorrectly lists a ceramic tip.
Product
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-0998-2019·2019-03-20
Ossur Skull Pin Recall for Labeling Error and Safety Testing
Ossur Americas is recalling 824 sterile skull pins due to a label error and pending safety testing.
Product
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN…
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-0999-2019·2019-03-20
Ossur OB Resolve Sterile Ring Kits Recalled for Labeling Errors
Ossur Americas is recalling 342 units of OB Resolve sterile ring kits due to a labeling error on titanium pins and pending safety testing.
Product
Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No…
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-1001-2019·2019-03-20
Ossur Halo System Ring Kits Recalled for Labeling and Safety Testing
Ossur Americas is recalling 182 units of Halo system ring kits due to a labeling error and the need for confirmatory safety testing.
Product
Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2…
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-1005-2019·2019-03-20
Zimmer NexGen Trabecular Metal Tibial Augment Recall for Label Mismatch
Zimmer Trabecular Metal Technology is recalling 24 units of NexGen Tibial Half Block Augments because the product in the box may not match the label.
Product
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1007-2019·2019-03-20
Olympus Ultrasound Gastrovideoscope Recalled Due to Adhesive Preparation Error
Olympus is recalling one ultrasound gastrovideoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.
Product
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0987-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0989-2019·2019-03-13
Maquet Flat Screen Monitor Holder Recalled for Grounding Non-Compliance
Getinge US Sales LLC is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0990-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling four Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0988-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling six Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0865-2019·2019-03-13
Raindrop Near Vision Inlay Recalled Due to Increased Risk of Corneal Haze
RVO 2.0, Inc. is recalling Raindrop Near Vision Inlays because a post-approval study found an increased risk of corneal haze following implantation.
Product
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0975-2019·2019-03-13
Draegar Medical Systems Recalls Omega Patient Monitor Software
Draegar Medical Systems is recalling Omega patient monitor software due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.
Product
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2019·2019-03-13
Siemens Uroskop Omnia Max Fluoroscopic X-ray System Recall for Swivel Arm Defect
Siemens is recalling 191 Uroskop Omnia Max fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
Product
Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0984-2019·2019-03-13
Siemens Uroskop Omnia Fluoroscopic X-ray System Recalled for Monitor Arm Defect
Siemens is recalling six Uroskop Omnia fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
Product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2019·2019-03-13
Stryker Reprocessed Arthroscopic Shavers Recalled for Display and Function Errors
Stryker is recalling 14,265 reprocessed arthroscopic shavers that may display incorrect settings or error messages, preventing proper use during surgery.
Product
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2019·2019-03-13
Abbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
Abbott is recalling Architect Magnesium assays because urine tests may show falsely low results. The recall covers 24,995 units distributed in the US and four other countries.
Product
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2019·2019-03-13
Draeger Infinity Delta Patient Monitors Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling Infinity Delta patient monitors due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.
Product
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2019·2019-03-13
Pentax C2 CryoBalloon Controller Recalled for Overpressure Detection Failure
Pentax of America Inc is recalling 45 C2 CryoBalloon Controllers because the device fails to detect balloon overpressure during specific nitrous oxide applications, posing a risk of patient injury.
Product
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2019·2019-03-13
Maquet Cardiovascular Recalls AXIUS Blower Mister Due to CO2 Flow Issues
Maquet Cardiovascular is recalling AXIUS Blower Mister devices because a potential lack of carbon dioxide flow may cause procedural delays during off-pump coronary artery bypass surgery.
Product
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2019·2019-03-13
BD MAX Enteric Bacterial Panel Recalled for False Negative Results
Becton Dickinson is recalling 1,583 BD MAX Enteric Bacterial Panel kits due to false negative results for specific bacterial targets.
Product
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0982-2019·2019-03-13
Cepheid Respiratory Control Panel Recalled for Reduced Expiration Date
Microbiologics Inc is recalling Cepheid Respiratory Control Panels because the expiration date was reduced from 24 months to 13 months.
Product
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0980-2019·2019-03-13
Stryker Recalls T2 Basic Long Instrument Sets Due to Mislabeling
Stryker GmbH is recalling 17 T2 Basic Long Instrument Sets because faceplates may incorrectly identify them as T2 Basic Short sets.
Product
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Category
Medical Device
Distribution
1 state

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21101–21125 of 40124