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

5076–5100 of 27375

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-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-2192-2024·2024-07-03
Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack
Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.
Product
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
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-2205-2024·2024-07-03
Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect
Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.
Product
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
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
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
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
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
HighFDA (Devices)·Z-2155-2024·2024-06-26
Exactech Knee Patella Components Recalled Due to Out-of-Specification Vacuum Bags
Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were distributed worldwide.
Product
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2151-2024·2024-06-26
Hospital bed mattress covers may delaminate from improper cleaning
Baxter Healthcare is recalling Centrella Max and Pro+ hospital bed mattresses that may develop delaminated top covers when cleaned with bleach-containing solutions. The mattresses prevent and treat pressure injuries.
Product
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) C
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-2157-2024·2024-06-26
OPTETRAK Inset Patella knee implants recalled for improper vacuum packaging
Exactech is recalling OPTETRAK Inset Patella knee implants packaged in out-of-specification vacuum bags that may compromise product integrity during storage or sterilization.
Product
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2152-2024·2024-06-26
Storage Case Design Flaw May Allow Reuse of Single-Use Surgical Instruments
Howmedica Osteonics Corp. is recalling HRIS Storage & Sterilization Cases (Part 6210-9-900) due to a design flaw that may allow reuse and resterilization of single-use, sterile instruments. This poses a contamination and infection risk.
Product
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2024·2024-06-26
FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect
Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.
Product
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2024·2024-06-26
PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.
Product
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2024·2024-06-26
NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid
NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.
Product
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2024·2024-06-26
Xstar Safety Slit Knife Recalled for Incorrect Blade Configuration
Beaver Visitec International is recalling 126 Xstar Safety Slit Knives with incorrect blade configuration. The recalled knives have the bevel oriented to the back instead of the front.
Product
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2024·2024-06-26
MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.
Product
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2150-2024·2024-06-26
TabloCart power cord connector may overheat in hemodialysis system
Outset Medical is recalling 431 TabloCart hemodialysis system carts due to power cord connector defects that may cause overheating, sparks, and smoke, potentially delaying treatment or causing burns.
Product
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2024·2024-06-26
Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect
Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.
Product
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2144-2024·2024-06-26
VICRYL Sutures recalled due to packaging defect compromising sterility
Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.
Product
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2024·2024-06-26
Bard Foley Catheter Trays Recalled for Temperature Display Malfunction
C.R. Bard Inc is recalling 6,420 Foley catheter trays nationwide because some devices may not display temperature readings or may display erratic readings. The malfunction could affect patient monitoring.
Product
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2146-2024·2024-06-26
PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.
Product
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2161-2024·2024-06-26
Xstar Safety Slit Knife Recalled for Incorrect Blade Bevel Orientation
Beaver Visitec International is recalling the Xstar Safety Slit Knife Model 378227 because some units have the blade bevel installed incorrectly—facing downward instead of the intended upward orientation.
Product
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

5076–5100 of 27375