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

6801–6825 of 39844

HighFDA (Devices)·Z-2182-2024·2024-07-03
Radiographic X-ray Table Recalled Due to Fire Hazard in Power Supply
Siemens AXIOM MULTIX MP radiographic X-ray tables are being recalled due to a potential short circuit in the touch display's power supply unit that may cause overheating or fire. 12 units nationwide are affected.
Product
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2024·2024-07-03
RingLoc Hip Acetabular Cup Recalled for Assembly Defect
Biomet recalled RingLoc hip acetabular cup components that may have been incorrectly assembled with a mismatched locking ring, potentially causing joint instability. Affected patients may require surgical intervention.
Product
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2024·2024-07-03
CentriMag Circulatory Support Console May Shut Down During Power Surge
CentriMag Primary Console units may completely shut down without alarm during power surges above 1.8kV, requiring emergency switch to backup circulatory support.
Product
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2024·2024-07-03
Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose
Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.
Product
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2024·2024-07-03
Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect
Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.
Product
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2024·2024-07-03
Medtronic COBALT XT HF CRT-D implantable defibrillator recalled for manufacturing defects
Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.
Product
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2024·2024-07-03
Implantable defibrillator recalled for manufacturing defect causing device failure risk
Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.
Product
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2024·2024-07-03
RAPIDPoint 500e diagnostic system mislabels capillary blood samples as arterial
Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.
Product
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2024·2024-07-03
D*Clot® HD Rotational Thrombectomy System Recalled for Sterility Barrier Defect
Mermaid Medical is recalling 190 D*Clot® HD Rotational Thrombectomy Systems worldwide due to failed sterility testing that indicates the sterility barrier may not be fully intact.
Product
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2024·2024-07-03
Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects
Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.
Product
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2181-2024·2024-07-03
Siemens X-ray Table Recalled for Fire Hazard in Power Supply
Siemens recalls AXIOM MULTIX MT radiographic X-ray tables due to a short circuit in the power supply unit that may cause overheating and fire. 7 units are affected nationwide.
Product
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2024·2024-07-03
Infinity M500 Cardiac Monitor Poses Electrical Shock Risk
Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.
Product
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2196-2024·2024-07-03
Medtronic EVERA S VR Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect
Medtronic is recalling EVERA S VR implantable cardioverter defibrillators due to a potential manufacturing defect involving a weld crack that can cause device failure. The defect was identified during manufacturing leak testing.
Product
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2024·2024-07-03
Medical imaging system recalled for power supply fire risk
Siemens is recalling 2 AXIOM Vertix MD imaging systems nationwide due to a potential fire hazard from a short circuit in the power supply unit that may cause overheating.
Product
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2024·2024-07-03
Medtronic COBALT DR MRI ICD Recalled for Manufacturing Defect
Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.
Product
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2024·2024-07-03
Implantable Defibrillator Recalled for Manufacturing Weld Crack Defect
Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.
Product
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2024·2024-07-03
FDA Recalls CUSA Excel Surgical Handpiece for Housing Cracks
Integra LifeSciences is recalling CUSA Excel C2600 surgical handpieces due to potential housing cracks that may delay treatment. The recall affects 2,652 units distributed nationwide and internationally.
Product
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2024·2024-07-03
Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units
Roche is recalling Accu-Chek Guide (SC) blood glucose meters that may display readings in mmol/L instead of mg/dL, appearing approximately 18 times lower than actual. This could lead to incorrect treatment decisions and long-term diabetes complications.
Product
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2220-2024·2024-07-03
CDC Influenza H5 Subtyping Kit may produce inconclusive test results
The CDC Influenza A/H5 Subtyping Kit's H5b component may fail to amplify, resulting in inconclusive results. 191 units were distributed nationwide.
Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2223-2024·2024-07-03
Cook Drainage Catheter Recall: Incorrect Expiration Date Labels
Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.
Product
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GP
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2178-2024·2024-07-03
Sonic Scaler Tip Holder May Be Oversized, Preventing Proper Seating
The tip holder portion of Titan Blis-Sonic Scaler tips may be oversized, preventing proper seating in the scaler handpiece. This defect could result in the tip becoming loose during use.
Product
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2130-2024·2024-06-26
Ventilator Operator's Guide Recalled for Missing Critical MRI Safety Information
ZOLL is recalling operator's guides for the ZOLL 731 Ventilator because they omit critical MRI safety information. Missing distance guidance could cause the ventilator to malfunction during MRI procedures.
Product
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2020-2024·2024-06-26
Ventilator HAMILTON-C6 may fail to restart, risking oxygen deprivation
Hamilton Medical AG is recalling the HAMILTON-C6 ventilator due to a sensor failure that may prevent re-initiation after reconnection, potentially causing hypoxia.
Product
Ventilator HAMILTON-C6, PN: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2153-2024·2024-06-26
Howmedica Gray Revision Instrument Tray Recalled for Design Enabling Instrument Reuse
Howmedica is recalling the Gray Revision Instrument System Accessory Tray/Case due to a design flaw that may enable reuse and re-sterilization of single-use, sterile-packaged instruments.
Product
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2024·2024-06-26
Exactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.
Product
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Category
Medical Device
Distribution
0 states

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6801–6825 of 39844