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

10426–10450 of 40095

HighFDA (Devices)·Z-1344-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2023·2023-04-12
Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.
Product
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2023·2023-04-12
Moberg CNS-350 Neuromonitoring System Recalled for Battery Leakage Risk
Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.
Product
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2023·2023-04-12
Medtronic Grafton Crunch sterile pouch packaging non-conformance recall
Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.
Product
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2023·2023-04-12
FDA Recalls VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System for Sterilization Failure
Maquet Cardiovascular is recalling VASOVIEW HEMOPRO endoscopic vessel harvesting systems because some batches were not sterilized to the required specifications.
Product
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2023·2023-04-12
Medtronic Grafton Plus Paste surgical implant recall due to packaging defects
Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.
Product
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T4500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2023·2023-04-12
Endoscopic vessel harvesting system recalled for sterilization defect
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
Product
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2023·2023-04-12
CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.
Product
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1319-2023·2023-04-12
Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1320-2023·2023-04-12
Biosense Webster guiding sheath recalled for labeling mismatch
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2023·2023-04-05
Iradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk
Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.
Product
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2023·2023-04-05
Chest Drain Valve Recalled for Insufficient Safety Instructions
The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2023·2023-04-05
Surgical navigation system recalled for potential mechanical instability
Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.
Product
Cirq Arm System 2.0
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1290-2023·2023-04-05
GaGa Pro Class IV Laser Projectors Recalled for FDA Compliance Failure
GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.
Product
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2023·2023-04-05
Disposable Tourniquet Cuffs Recalled Due to Pressure Failure
Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.
Product
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1291-2023·2023-04-05
Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals
Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.
Product
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1312-2023·2023-04-05
Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk
Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.
Product
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1306-2023·2023-04-05
FDA recalls ACL ELITE refurbished analyzer to remove Anti-Xa test
Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.
Product
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2023·2023-04-05
Irvine Scientific embryo culture oil recalled due to detected toxicity
Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.
Product
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1294-2023·2023-04-05
CoCr Femoral Head hip implant compatibility removed due to motion limitations
Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.
Product
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1311-2023·2023-04-05
Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk
Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.
Product
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1300-2023·2023-04-05
PCRopsis Reagent RVD-RT in vitro diagnostic kit recall for misleading labels
Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT diagnostic kits due to misleading label statements that could affect proper use and test interpretation.
Product
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1316-2023·2023-04-05
Baxter Automated Peritoneal Dialysis System Electrical Safety Testing Failure
Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1318-2023·2023-04-05
Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks
Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.
Product
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1304-2023·2023-04-05
ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
Product
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Category
Medical Device
Distribution
Distributed nationwide

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10426–10450 of 40095