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

4651–4675 of 13449

HighFDA (Devices)·Z-0277-2025·2024-11-06
Smith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0249-2025·2024-11-06
Surgical patties and strips recalled for endotoxin contamination
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.
Product
SURG STRP 1/4X6 Model/Catalog Number: 801450. 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
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
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-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
SevereFDA (Devices)·Z-0074-2025·2024-10-30
Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection
Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.
Product
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are 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 adminis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0076-2025·2024-10-30
Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk
Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire 7900. 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-0075-2025·2024-10-30
Aespire 100 anesthesia machine breathing circuit misconnection FDA recall
Datex-Ohmeda Aespire 100 anesthesia machines are recalled due to potential misconnection of breathing circuit limbs to the Auxiliary Common Gas Outlet port, which could impair anesthesia or ventilation delivery.
Product
Aespire 100. 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-0081-2025·2024-10-30
Anesthesia Machine Recall Due to Patient Breathing Circuit Misconnection Risk
Datex-Ohmeda Aisys anesthesia machines may allow patient breathing circuits to be incorrectly connected to the Auxiliary Common Gas Outlet, potentially affecting ventilation during anesthesia. Approximately 4,790 units worldwide are affected.
Product
Aisys. 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
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-0080-2025·2024-10-30
Anesthesia gas machines pose risk of breathing circuit misconnection
Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.
Product
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are 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-0046-2025·2024-10-30
Life2000 Ventilator May Fail to Alarm on Low Gas Pressure
Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.
Product
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0210-2025·2024-10-30
Baxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk
Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.
Product
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0193-2025·2024-10-30
Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect
Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.
Product
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0134-2025·2024-10-30
Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error
Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.
Product
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0185-2025·2024-10-30
Medex TranStar pressure monitoring kit recalled for manufacturing defect
Smiths Medical ASD is recalling the medex TRANSTAR MONITORING KIT due to a manufacturing defect that may cause inaccurate pressure readings, monitoring interruption, or inability to zero the device. Affected units have Lot Number 4270117.
Product
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0174-2025·2024-10-30
Medline convenience kits recalled for potential use of non-sterile product
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
Product
Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2025·2024-10-30
medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect
Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.
Product
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0183-2025·2024-10-30
Medex TranStar ICP Pressure Monitoring Device Recalled Due to Manufacturing Defect
Smiths Medical is recalling the medex TranStar Single ICP Set because a manufacturing defect may cause inaccurate pressure monitoring, monitoring interruptions, or inability to zero the device.
Product
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0014-2025·2024-10-30
CADD Medication Cassette Reservoir weld defect poses leakage risk
Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.
Product
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0169-2025·2024-10-30
Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0016-2025·2024-10-30
CADD Medication Cassette Reservoir Recall Due to Defective Weld Joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs with defective weld joints that may cause medication leakage. The issue affects 8,976 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0216-2025·2024-10-30
Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards
Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.
Product
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Category
Medical Device
Distribution
0 states

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4651–4675 of 13449