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

12601–12625 of 13802

ModerateFDA (Devices)·Z-0275-2022·2021-12-01
da Vinci Surgical Drapes Recalled for Incorrect Expiration Date on Packaging
Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.
Product
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instru
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0297-2022·2021-12-01
Siemens Artis zee x-ray system may delay imaging delivery during procedures
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Product
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0240-2022·2021-12-01
Medical X-Ray Systems Missing Required Radiation Warning Labels
Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.
Product
ProxiDiagnost N90 is multi-functional general R/F systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0304-2022·2021-12-01
Siemens Artis Q.zen Angiography System X-ray Activation Failure
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.
Product
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0284-2022·2021-12-01
CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays
A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.
Product
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0300-2022·2021-12-01
Siemens Artis Q floor angiography system: X-ray failure during SID lift operation
Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.
Product
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0302-2022·2021-12-01
Siemens Artis Q Biplane X-ray System Software Imaging Delay Issue
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.
Product
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0298-2022·2021-12-01
Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
Product
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0231-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall
The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0233-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk
Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0225-2022·2021-11-24
Scrip Creme ultrasound lotion recalled for bacterial contamination
Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.
Product
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0234-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk
Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0232-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall
Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0224-2022·2021-11-24
FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination
Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.
Product
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2022·2021-11-24
SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.
Product
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0261-2022·2021-11-24
Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure
CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.
Product
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0265-2022·2021-11-24
Smith & Nephew EVOS Self-Tapping Locking Screws recalled due to switched package labels
Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws because package labels were switched, creating a risk that incorrect screw sizes could be implanted during surgery.
Product
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0230-2022·2021-11-24
Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling
Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.
Product
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0250-2022·2021-11-24
REGARD Basic Cataract Tray Recalled for Out-of-Specification Component
ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.
Product
REGARD Basic Cataract tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0251-2022·2021-11-24
REGARD Core Biopsy Tray Recalled for Out-of-Specification Component
ROi CPS LLC recalled 1,200 REGARD Core Biopsy Trays distributed nationwide because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications.
Product
REGARD Core Biopsy Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0255-2022·2021-11-24
REGARD Ultrasound Trays Recalled for Out-of-Specification Swabstick Component
ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.
Product
REGARD Ultrasound Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0259-2022·2021-11-24
LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure
CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.
Product
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0221-2022·2021-11-24
SMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement
Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.
Product
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0245-2022·2021-11-24
Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect
Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.
Product
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0235-2022·2021-11-24
Syphilis Test Reagent Pack Recalled Due to False Positive Results
Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.
Product
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
Category
Medical Device
Distribution
Distributed nationwide

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12601–12625 of 13802