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

351–375 of 39760

HighFDA (Devices)·Z-2694-2026·2026-07-15
Intracept Access Instruments sterile barrier breach risk
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Product
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2703-2026·2026-07-15
Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2677-2026·2026-07-15
Aquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.
Product
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2676-2026·2026-07-15
Olympus Single Use Distal Cover MAJ-2315 Duodenovideoscope Replacement
Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.
Product
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flex
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2701-2026·2026-07-15
EMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
Encore Medical is recalling EMPOWR 3D KNEE insertion instruments because some packages contain incorrect product sizes due to a packaging discrepancy.
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2700-2026·2026-07-15
EMPOWR 3D Knee surgical device recalled due to packaging discrepancy
Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2699-2026·2026-07-15
KL Owen Custom Orthodontic Solution bracket placement defect
Klowen Braces is recalling 3 units of the KL Owen Custom Orthodontic Solution (model CIAS-800033) due to a product error that may cause incorrect bracket placement.
Product
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2714-2026·2026-07-15
OmniTract Surgical Retractor System sterilization instructions require extended dry time
Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.
Product
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2695-2026·2026-07-15
Medline Anesthesia Kit Peds Contains Defective Temperature Probes
Medline Industries is recalling Anesthesia Kit Peds (Model DYNJAP10125A, Lot 24JBR072) nationwide because they contain Covidien Mon-a-Therm temperature probes affected by a distribution control error.
Product
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2697-2026·2026-07-15
Medline Open Heart Peds Pack Convenience Kits Temperature Probe Recall
Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.
Product
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2702-2026·2026-07-15
5008X Blood Tubing Set connection errors FDA Class II recall
Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.
Product
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF St
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2713-2026·2026-07-15
GSP Neonatal GALT Kit in vitro diagnostic test equipment
WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.
Product
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2696-2026·2026-07-15
Medline Convenience Kits containing temperature probes recalled
Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.
Product
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2717-2026·2026-07-15
Versius Surgical System Console affected by cybersecurity vulnerability
CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.
Product
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2604-2026·2026-07-08
Omnipod DASH Pod insulin pump affected by external cannula damage
Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.
Product
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2026·2026-07-08
Reprocessed Electrophysiology Catheters Recalled for Residual Particles
Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.
Product
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2549-2026·2026-07-08
Hillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.
Product
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2607-2026·2026-07-08
Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects
Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2624-2026·2026-07-08
Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
Product
Medtronic Harmony Delivery Catheter System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2610-2026·2026-07-08
Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing Swan-Ganz catheters are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may lead to infection, medication loss, and blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2603-2026·2026-07-08
Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.
Product
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2640-2026·2026-07-08
Cyberknife Treatment Delivery System Collimator Docking Failure Risk
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2672-2026·2026-07-08
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.
Product
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2551-2026·2026-07-08
Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
Product
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2621-2026·2026-07-08
Preop Kit-NS surgical kits recalled for bacterial contamination
A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Category
Medical Device
Distribution
Distributed nationwide

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