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

11501–11525 of 13816

HighFDA (Devices)·Z-1402-2022·2022-07-27
Stryker Triton Canister Scanning Labels Recalled Due to Color Variance
Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2022·2022-07-27
Medical Bed Mattress Microclimate Failure Increases Pressure Ulcer Risk
Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.
Product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2022·2022-07-27
Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
Product
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1419-2022·2022-07-27
Orthopedic Surgical Guide with Defective Spring Subject to Corrosion
DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.
Product
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1452-2022·2022-07-27
SurgiCount+ System software error bypasses sponge tracking alerts
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
Product
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1408-2022·2022-07-27
Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1420-2022·2022-07-27
Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk
Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.
Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2022·2022-07-27
Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Product
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1413-2022·2022-07-27
Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk
Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.
Product
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2022·2022-07-27
Hobbs Medical Polypectomy Snare May Fail to Close Properly
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1430-2022·2022-07-27
SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.
Product
SIGNA Premier magnetic resonance scanner, model 5748519.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2022·2022-07-27
Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2022·2022-07-27
BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage
Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.
Product
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1394-2022·2022-07-27
Triton Sponge System Software Instructions Updated for Proper Sponge Handling
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1451-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-1423-2022·2022-07-27
Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Product
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1422-2022·2022-07-27
Laboratory Reagent Recalled Due to Inaccurate Calibration Curves
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Product
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2022·2022-07-27
Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Product
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2022·2022-07-27
GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1404-2022·2022-07-27
X80 RADiant Photoelectric Therapy System Compatibility Issue
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Product
X80 RADiant Photoelectric Therapy System
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1390-2022·2022-07-27
Erythropoietin Control Product Instructions Contain Incorrect CE Marking
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Product
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1393-2022·2022-07-27
NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing S
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-1349-2022·2022-07-20
CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Product
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1346-2022·2022-07-20
CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints
Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.
Product
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1371-2022·2022-07-20
Hemodialysis Dialysate Recalled for Unqualified Bottle Caps
Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.
Product
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Category
Medical Device
Distribution
0 states

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11501–11525 of 13816