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

3776–3800 of 39987

HighFDA (Devices)·Z-1955-2025·2025-06-18
Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall
Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.
Product
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2025·2025-06-18
Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall
Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.
Product
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2025·2025-06-18
Solana Bordetella Complete Assay Kit Recalled for False Positive Results
Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.
Product
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1923-2025·2025-06-18
Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk
Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1916-2025·2025-06-18
Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.
Product
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2025·2025-06-18
Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall
Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, or death.
Product
Intera 1.5T Master/Nova Product Number: 781106;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2025·2025-06-18
Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly
Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.
Product
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1926-2025·2025-06-18
DxI 9000 Access Immunoassay Analyzer software version 1.20 recall
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2025·2025-06-18
Guardian System 2 Controller units recalled for battery alert display defect
Turncare has recalled certain Guardian 2 System controllers because a software issue prevented "low" and "terminal" battery alerts from displaying on the screen in specific circumstances when the device was not running patient therapy.
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2025·2025-06-18
Guardian System 2 Controller Software Battery Alert Display Issue
Turncare is recalling Guardian System 2 Controllers due to a software issue where low and terminal battery alerts do not display on the screen in certain circumstances when the device is not running patient therapy.
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2025·2025-06-18
BD BBL CultureSwab EZ Collection and Transport System Swabs Breakage
BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.
Product
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1947-2025·2025-06-18
Thermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
Remel, Inc. is recalling one lot of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth due to off-color that may affect performance of this in-vitro diagnostic device.
Product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1964-2025·2025-06-18
Baxter Novum IQ Syringe Pump Design Issue Recall
Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.
Product
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1814-2025·2025-06-11
Adult Manual Resuscitator with Medium Adult Mask recalled nationwide
SunMed Holdings is recalling 11,358 Adult Manual Resuscitators because the filter may be incorrectly attached to the patient port instead of the exhalation port, risking interruption or delay in patient resuscitation that could cause serious harm or death.
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1810-2025·2025-06-11
Medline Craniotomy Kits with Defective Codman Disposable Perforators
Medline is recalling craniotomy kits containing Codman Disposable Perforators with inadequate welds that may break or separate during use.
Product
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1811-2025·2025-06-11
Medline Craniotomy Kits with Defective Codman Disposable Perforators Recalled
Medline is recalling multiple craniotomy kits containing Codman Disposable Perforators due to inadequate welds that may cause the perforators to break or separate during use.
Product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYN
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1809-2025·2025-06-11
Medline Surgical Kits with Codman Disposable Perforator recalled
Medline surgical kits containing Codman Disposable Perforators are being recalled because certain lots have inadequate welds that may cause the perforator to break or separate during use.
Product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1897-2025·2025-06-11
Signature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall
Silex Medical is recalling 6 units of the Signature Laparoscopic Bullet Tip Grasper with Rotating Shaft due to incomplete insulation on the shaft near the rotator wheel, which could expose users to electrical hazards.
Product
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1900-2025·2025-06-11
Signature Laparoscopic Atraumatic Grasper Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Instruments (Model 5881033) because insulation on the shaft does not fully extend to the proximal end, leaving an exposed area near the rotator wheel.
Product
Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1885-2025·2025-06-11
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack Recalled
Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. Affected units were distributed worldwide including the US, Canada, and Mexico.
Product
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2025·2025-06-11
Olympus EVIS EXERA III Duodenovideoscope TJF-Q190V Contamination Risk
Olympus is recalling the EVIS EXERA III Duodenovideoscope Model TJF-Q190V due to post-market data showing higher microbial contamination when manual cleaning is delayed beyond one hour after patient use.
Product
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2025·2025-06-11
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack Recalled
Mozarc Medical is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Packs due to a potential breach of sterile barrier packaging that could compromise the catheter's sterility.
Product
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2025·2025-06-11
Signature Laparoscopic Allis Clamp Grasper with Rotating Shaft Recalled
Silex Medical is recalling the Signature Laparoscopic Instruments Allis Clamp Grasper due to incomplete insulation on the shaft, leaving an exposed area that could pose an electrical hazard during surgical procedures.
Product
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2025·2025-06-11
ChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
Healthmark Industries is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes (Models UCC-222CP and UCC-222-ESP) because contamination was found in duodenoscope samples linked to the syringes, which were improperly used outside their intended purpose.
Product
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1896-2025·2025-06-11
Signature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall
Silex Medical recalls the Signature Laparoscopic Sharp Tooth Grasper due to incomplete insulation on the shaft near the rotator wheel, which creates an electrical hazard during use.
Product
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
Category
Medical Device
Distribution
Distributed nationwide

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3776–3800 of 39987