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

4701–4725 of 13526

HighFDA (Devices)·Z-0140-2025·2024-11-06
GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
Product
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0255-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher Endotoxin Levels
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.
Product
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0262-2025·2024-11-06
Dural Graft Implants Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant (Model 80-1477US, Lot CT007694) due to endotoxin levels exceeding specifications. No adverse events have been reported.
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0243-2025·2024-11-06
Surgical Patties and Strips Recalled for Endotoxin Contamination
Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.
Product
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0236-2025·2024-11-06
Codman Surgical Patties Recalled for Endotoxin Contamination
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.
Product
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0245-2025·2024-11-06
Codman Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.
Product
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0257-2025·2024-11-06
Covidien Chameleon PTA Balloon Catheter Recalled for Failed Pressure Testing
Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.
Product
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US),
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0253-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.
Product
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2025·2024-11-06
Surgical Patties and Strips recalled for endotoxin contamination in raw materials
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.
Product
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0244-2025·2024-11-06
Surgical patties and strips recalled for elevated endotoxin levels in raw materials
Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.
Product
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2025·2024-11-06
Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin
Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.
Product
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.
Product
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0233-2025·2024-11-06
Abbott Alinity m HPV test kit control failures from iron contamination
Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.
Product
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0228-2025·2024-11-06
Hospital Bed Fails to Send Remote Alerts Through Nurse Call System
Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.
Product
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0241-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.
Product
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0231-2025·2024-11-06
ClariTEE Probe Ultrasound Recall Due to Defective Epoxy Sealing
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
Product
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0254-2025·2024-11-06
Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Product
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0247-2025·2024-11-06
Surgical patties and strips recalled for elevated endotoxin levels
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
Product
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0230-2025·2024-11-06
LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Product
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 int
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0260-2025·2024-11-06
Surgical tracking device patient labels show incorrect expiration date
Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.
Product
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0276-2025·2024-11-06
KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use
King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.
Product
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0258-2025·2024-11-06
17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy
DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.
Product
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0078-2025·2024-10-30
Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.
Product
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0082-2025·2024-10-30
Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.
Product
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0083-2025·2024-10-30
Aisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard
Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.
Product
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide

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4701–4725 of 13526