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

12776–12800 of 40151

HighFDA (Devices)·Z-0849-2022·2022-04-06
Radiation therapy planning software: incorrect dose density calculation
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2022·2022-04-06
Hip prosthetic femoral head component size and offset labeling mismatch
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2022·2022-04-06
Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2022·2022-04-06
BALLARD Multi-Access Port Catheter Recalled for Incorrect Expiration Date
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
Product
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2022·2022-04-06
Tissue oximeter module may provide inaccurately low oxygen readings
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Product
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2022·2022-04-06
FORE-SIGHT ELITE Tissue Oximeter: Inaccurate Oxygen Saturation Readings
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Product
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2022·2022-04-06
Surgical Drill System Instrument Pack Recalled Over Device Breakage Risk
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
Product
EasyFuse Dynamic Compression System Instrument Pack
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0841-2022·2022-04-06
Radiographic system software error may cause unintended tube stand movement
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Product
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2022·2022-04-06
Ceramic Hip Femoral Head Component May Not Match Package Label
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Product
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2022·2022-04-06
CareFusion Endoscopic Equipment Recalled for Missing Instructions for Use
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
Product
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0831-2022·2022-04-06
Baxter Healthcare MiniCap Extended Life PD Transfer Sets Recalled for Regulatory Non-Compliance
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. states.
Product
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0846-2022·2022-04-06
BALLARD Multi-Access Port Catheter Distributed With Incorrect Expiration Dates
Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.
Product
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0837-2022·2022-04-06
Regard Custom Procedure Kits with BD Luer Lok Access Devices Recalled
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0828-2022·2022-04-06
Cobas Liat respiratory virus analyzer units recalled for false Influenza B results
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
Product
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0845-2022·2022-04-06
BALLARD Seal Cassette Replacement catheters recalled for incorrect expiration date
Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.
Product
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0844-2022·2022-04-06
Medical Device Manufacturer Recalls Quality Control Panel for Incorrect Shelf-Life
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
Product
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0838-2022·2022-04-06
Surgical Gloves Recalled Due to Missed FDA Border Inspection
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
Product
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0785-2022·2022-03-30
Philips Respironics respiratory ventilators recalled for foam degradation
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0823-2022·2022-03-30
NuOss Collagen Blocks Recalled Due to Product Substitution Error
Ace Surgical Supply is recalling NuOss Collagen Blocks because some units were mistakenly packaged with Collatene Fibrillar Collagen instead, which may result in suboptimal bone repair during dental and maxillofacial procedures.
Product
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0821-2022·2022-03-30
Medical Device Air Supply Unit Recalled for Potential Electrical Shock Hazard
Baxter Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.
Product
Compella Therapy Air Supply Unit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0819-2022·2022-03-30
Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices
B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.
Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0817-2022·2022-03-30
Codman Cranial Access Kits Recalled Due to Incorrect Expiration Dates on Labels
Integra LifeSciences is recalling 1,161 Codman Cranial Access Kits due to incorrect expiration dates on the outer box labels. Using the product past its correct expiration date may cause pain, infection, or adverse tissue reaction.
Product
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2022·2022-03-30
Codman Cranial Access Kits Recall: Incorrect Expiration Dates on Labels
Integra LifeSciences is recalling Codman Cranial Access Kits due to incorrect extended expiration dates printed on outer box labels. Using expired kits may result in pain, infection, or adverse tissue reaction.
Product
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0813-2022·2022-03-30
Outset Tablo Hemodialysis Console Recalled for Heat Damage Risk
Outset Medical is recalling Tablo hemodialysis consoles (models PN-0003000 and PN-0006000) nationwide due to a component that may cause heat-related damage to the device.
Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0820-2022·2022-03-30
Compella Bariatric Bed System Recall—Power Cord Electrical Shock Risk
Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide are affected.
Product
Compella Bariatric Bed System
Category
Medical Device
Distribution
Distributed nationwide

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12776–12800 of 40151