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-1464-2022·2022-08-03
AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk
Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.
Product
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1473-2022·2022-08-03
Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol
Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.
Product
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2022·2022-08-03
Medline medical device kits recalled for leaking isopropyl alcohol bottles
Medline Industries is recalling medical convenience kits containing leaking bottles of isopropyl alcohol due to chemical exposure risk. The recall affects 288 units distributed nationwide.
Product
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1457-2022·2022-08-03
X-Stream Irrigation System recalled due to potential fire hazard
Davol, Inc. is recalling the X-Stream Irrigation System due to a potential fire hazard. The device may cause a fire during use, creating a safety risk.
Product
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
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-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-1480-2022·2022-08-03
Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect
Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2022·2022-08-03
GE Centricity PACS Software fails to notify of exam study modifications
GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.
Product
Centricity PACS Software Version 7.0 SP0.0.4.7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1477-2022·2022-08-03
Medical Device Kits Recalled for Leaking Isopropyl Alcohol
Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.
Product
Z-1477-2022
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1459-2022·2022-08-03
Da Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion
Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.
Product
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
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-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
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-1475-2022·2022-08-03
Medline skin prep kits recalled due to leaking isopropyl alcohol bottles
Medline Industries is recalling 1,880 units of skin prep convenience kits with models DYNDP1127A and DYNDP1131 distributed nationwide due to leaking bottles of isopropyl alcohol.
Product
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Category
Medical Device
Distribution
Distributed nationwide
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-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-1447-2022·2022-07-27
Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect
Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.
Product
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2022·2022-07-27
Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue
Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1431-2022·2022-07-27
BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage
BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.
Product
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2022·2022-07-27
Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2022·2022-07-27
Surgical Coronal Bender May Deform Spinal Implants During Surgery
Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.
Product
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1428-2022·2022-07-27
Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk
Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
Distribution
Distributed nationwide

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11351–11375 of 13717