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-0305-2022·2021-12-01
Siemens Artis Q.zen Angiography System X-Ray Imaging Delay Issue
Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.
Product
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0303-2022·2021-12-01
Siemens Artis Q.zen Angiography System May Fail to Fire X-rays During Simultaneous Operations
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Product
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
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
ModerateFDA (Devices)·Z-0299-2022·2021-12-01
Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.
Product
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
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-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-0296-2022·2021-12-01
Medical Imaging System May Fail to Release X-rays Under Specific Conditions
Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.
Product
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
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-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-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
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-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
HighFDA (Devices)·Z-0220-2022·2021-11-24
Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.
Product
SMART FLEX 10x100 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-0260-2022·2021-11-24
LEEP PRECISION Surgical Generator May Fail to Coagulate During Surgery
CooperSurgical is recalling 75 units of the LEEP PRECISION Generator 220V because the coagulation hand switch may fail, potentially causing uncontrolled bleeding during surgery.
Product
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0236-2022·2021-11-24
Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues
Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.
Product
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0253-2022·2021-11-24
REGARD Newborn Tray Recalled Due to Out-of-Spec Antiseptic Component
ROi CPS LLC is recalling REGARD Newborn Trays (lot 86453F) distributed in FL, LA, and MO because some units contain a povidone-iodine swabstick component manufactured out of specifications.
Product
REGARD Newborn Tray
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-0223-2022·2021-11-24
Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk
Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.
Product
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0227-2022·2021-11-24
Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle
Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.
Product
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0244-2022·2021-11-24
Bodycad Torque Limiting Adaptor Recalled for Breakage Risk
Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.
Product
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0254-2022·2021-11-24
Out-of-Specification Swabstick Recalled in REGARD Stereotactic Tray
ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.
Product
REGARD Stereotactic Tray
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-0228-2022·2021-11-24
Beaver Xstar Crescent Knife Surgical Blades Recalled for Wrong Blade Orientation
Beaver Visitec International recalls CustomEyes Cataract Surgical Kits containing Xstar Crescent Knives with incorrect blade orientation. Kits labeled as 55-degree bevel-down blades actually contain bevel-up blades.
Product
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
Category
Medical Device
Distribution
Distributed nationwide

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12601–12625 of 13802