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

5976–6000 of 13512

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
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
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-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-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-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
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-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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-2156-2024·2024-06-26
OPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags
Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.
Product
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1921-2024·2024-06-19
Thoratec HeartMate System Monitor display malfunction in left ventricular assist devices
The Thoratec HeartMate System Monitor is being recalled due to display malfunctions affecting 4,842 devices worldwide. These issues may prevent proper monitoring and device control.
Product
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2024·2024-06-19
CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall
Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.
Product
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2024·2024-06-19
VITROS Immunodiagnostic Calibrators Recalled for Potential Accuracy Bias
Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.
Product
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Category
Medical Device
Distribution
Distributed nationwide

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