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

9651–9675 of 27441

SevereFDA (Devices)·Z-1376-2022·2022-08-03
ABACUS TPN Calculation Software recalled for medication error risk
Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.
Product
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE)…
Category
Medical Device
Distribution
1 state
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-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-1453-2022·2022-08-03
NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information
NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.
Product
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc…
Category
Medical Device
Distribution
10 states
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
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-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-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-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-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-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-1461-2022·2022-08-03
Blood Glucose Meter Recalled for Marketing Without FDA Clearance
Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.
Product
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Category
Medical Device
Distribution
Distributed nationwide
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…
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.…
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-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…
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-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-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-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-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-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-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-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-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…
Category
Medical Device
Distribution
Distributed nationwide

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9651–9675 of 27441