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

11351–11375 of 13717

HighFDA (Devices)·Z-1476-2022·2022-08-03
Medline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles
Medline has recalled custom neurosurgical procedure kits nationwide due to leaking bottles of isopropyl alcohol. The leakage poses a risk of contamination and chemical exposure during surgical procedures.
Product
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1479-2022·2022-08-03
Revogene diagnostic test instrument recalled for burn risk from cooling failure
Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.
Product
Revogene, Catalog no. 610210. IVD test instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2022·2022-08-03
TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure
Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.
Product
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1478-2022·2022-08-03
Stryker Craniotomy Router May Break and Leave Metal Fragments
Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.
Product
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2022·2022-08-03
Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles
Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.
Product
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2022·2022-08-03
HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating
Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.
Product
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2022·2022-08-03
Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results
Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.
Product
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-1469-2022·2022-08-03
Hematology Analyzer Sight OLO Displays Incorrect Pediatric Reference Ranges
The Sight OLO automated hematology analyzer displays mixed-up default reference ranges for children ages 2-11 in software versions 2.63, 2.63.1, and 2.63.1.1, which could cause test results to appear incorrectly normal or abnormal.
Product
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2022·2022-08-03
Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results
Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.
Product
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-1460-2022·2022-08-03
Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion
Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.
Product
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2022·2022-08-03
Medical imaging software may flip left-right brain image orientation
NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.
Product
nordicBrainEX, software versions 2.21 through 2.3.10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2022·2022-08-03
Medline Medical Kits Recalled for Leaking Isopropyl Alcohol
Medline convenience kits containing leaking bottles of isopropyl alcohol are being recalled. Approximately 477 units were distributed nationwide and should not be used.
Product
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2022·2022-08-03
Dialysis Machine Recalled for Electrical Shock Risk in AquaC UNO H
The FDA is recalling 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.
Product
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1474-2022·2022-08-03
Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol
Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.
Product
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2022·2022-08-03
Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results
Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.
Product
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-1458-2022·2022-08-03
Paragon 28 Gorilla Plating System Drill Recalled for Incorrect Packaging Label
Paragon 28, Inc. has recalled Baby Gorilla/Gorilla Plating System drills (Ref: P99-100-2816) because the drill packaging may contain incorrect part numbers.
Product
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1465-2022·2022-08-03
ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label
Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.
Product
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1389-2022·2022-07-27
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.
Product
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2022·2022-07-27
BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2022·2022-07-27
Sensis Vibe Combo Device Recalled for Software Communication Failure
The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.
Product
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1387-2022·2022-07-27
SX-One MicroKnife Recalled for Potential Dull Blade Defect
Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.
Product
SX-One MicroKnife
Category
Medical Device
Distribution
Distributed nationwide
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-1421-2022·2022-07-27
Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1412-2022·2022-07-27
Hill-Rom PRO+ Mattress Microclimate Management Failure Increases Pressure Ulcer Risk
Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.
Product
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2022·2022-07-27
Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance
Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.
Product
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Category
Medical Device
Distribution
Distributed nationwide

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11351–11375 of 13717