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

10451–10475 of 27441

HighFDA (Devices)·Z-0499-2022·2022-01-26
FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.
Product
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0508-2022·2022-01-26
Cardinal Infant Heel Warmer recalled due to unapproved labeling changes
Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.
Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0502-2022·2022-01-26
Blood Collection Tubes Recalled Due to Lithium Heparin Variation
Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.
Product
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-0468-2022·2022-01-19
Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.
Product
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0476-2022·2022-01-19
Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues
Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.
Product
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2022·2022-01-19
Proton Therapy System software startup allows test processes to contaminate clinical environment
The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.
Product
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0491-2022·2022-01-19
Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing
Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.
Product
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2022·2022-01-19
Computed Tomography System Software May Degrade Head Image Quality
Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.
Product
SOMATOM Edge Plus-Computed tomography system Model 1026700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0477-2022·2022-01-19
OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk
Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.
Product
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2022·2022-01-19
CT Scanner Software Defect May Degrade Image Quality Nationwide
Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.
Product
SOMATOM Confidence -Computed tomography systems Model 10590100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0492-2022·2022-01-19
Flat Panel Detector May Display Abnormal Images During Surgical Procedures
Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.
Product
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2022·2022-01-19
GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall
DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.
Product
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0485-2022·2022-01-19
DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal
DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.
Product
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2022·2022-01-19
Hip stem implants recalled due to undersized bore defect
DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.
Product
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0483-2022·2022-01-19
Hip Stem Component Recalled Due to Undersized Bore Diameter
DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.
Product
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0479-2022·2022-01-19
Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors
PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.
Product
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2022·2022-01-19
OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units
Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.
Product
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2022·2022-01-19
CT Scanner Software Update Causes Head Image Quality Degradation
Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.
Product
SOMATOM Definition Edge -Computed tomography system Model 10590000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2022·2022-01-19
LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect
Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.
Product
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0488-2022·2022-01-19
Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect
DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.
Product
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2022·2022-01-19
CT Scanner Software Defect May Degrade Image Quality
Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.
Product
SOMATOM Definition AS-Computed tomography system Model 8098027
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0465-2022·2022-01-19
Subdermal Needle Electrode Corkscrew Recall: Risk of Blue Hub Detachment
Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.
Product
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0487-2022·2022-01-19
Orthopaedic Implant Stems Recalled for Undersized Spigot Bore Defect
DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.
Product
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2022·2022-01-19
Sterilized medical convenience kits recalled for missing latex warning label
ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits due to missing rubber latex warning labels. Consumers with latex allergies face risk of allergic reaction if exposed to the unlabeled latex.
Product
Regard, T AND A - Rogers, sterilized convenience kits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0490-2022·2022-01-19
Hip prosthetic stem undersized bore complicates removal surgery
DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.
Product
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Category
Medical Device
Distribution
Distributed nationwide

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10451–10475 of 27441