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

201–225 of 39884

ModerateFDA (Devices)·Z-2908-2026·2026-08-12
COAPTIUM CONNECT medical device shelf life recalibration recall
TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2905-2026·2026-08-12
COAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2838-2026·2026-08-12
Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.
Product
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radia
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2895-2026·2026-08-12
Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
Product
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2881-2026·2026-08-12
Siemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
Product
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2910-2026·2026-08-12
Blom-Singer Voice Prosthesis Recalled Due to Incorrect Labeling
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2867-2026·2026-08-12
Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2880-2026·2026-08-12
Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
Product
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2735-2026·2026-08-05
ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk
ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.
Product
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2792-2026·2026-08-05
Cardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
Medical Action Industries is recalling cardiovascular procedure kits containing manifolds that may have particulate in the fluid path, which could enter blood circulation and lodge in blood vessels. FDA Class I.
Product
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2807-2026·2026-08-05
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.
Product
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2819-2026·2026-08-05
Medical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues
Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2809-2026·2026-08-05
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.
Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2650-2026·2026-08-05
Philips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.
Product
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2652-2026·2026-08-05
Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.
Product
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2829-2026·2026-08-05
Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm due to a potential risk of the rods cracking after cleaning and sterilization.
Product
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2802-2026·2026-08-05
Medical convenience kits recalled due to potential endotoxin level variability
Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2651-2026·2026-08-05
Philips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.
Product
IQon Spectral CT IQon Spectral CT Upgrades
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2808-2026·2026-08-05
Arterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, and organ dysfunction.
Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2804-2026·2026-08-05
Midline Catheter Recalled Over Risk of Leaking or Cracking at Hub
Argon Medical Devices is recalling its L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm (REF 384620) because the hub may leak or crack, potentially causing therapy interruption, blood loss, or bloodstream infection.
Product
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-2820-2026·2026-08-05
OsteoBallast and Ballast bone graft extenders recalled due to insufficient material volume
IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.
Product
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2823-2026·2026-08-05
Portable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk
Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.
Product
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2833-2026·2026-08-05
Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 150mm due to the potential for the rods to crack following cleaning and sterilization processes.
Product
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2812-2026·2026-08-05
Medical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection
Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2806-2026·2026-08-05
Arterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass
Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Product
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Category
Medical Device
Distribution
Distributed nationwide

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201–225 of 39884