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

7101–7125 of 13683

SevereFDA (Devices)·Z-1166-2024·2024-03-06
Medtronic Duet Catheter System Recalled for Potential Disconnection Risk
Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1134-2024·2024-03-06
Medical device kits recalled due to potential sterility failure
Medline Industries is recalling IV securement kits and neonatal PICC line insertion trays due to potential lack of sterility in Nurse Assist components. Approximately 11,812 units are affected.
Product
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1115-2024·2024-03-06
Blood Draw and Lab Collection Kits Recalled for Potential Sterility Defect
Medline Industries is recalling blood draw and lab collection kits due to potential lack of sterility in component solutions. The affected kits could contain non-sterile solutions, posing risks in clinical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2024·2024-03-06
Medline Suction Catheter Kits Recalled for Potential Sterility Defects
Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1064-2024·2024-03-06
AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation
Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.
Product
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1092-2024·2024-03-06
MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure
MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2024·2024-03-06
Medline Prep Kits Recalled Due to Non-Sterile Components
Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1103-2024·2024-03-06
Medline surgical kits and trays recalled for sterility defects
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1117-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.
Product
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1165-2024·2024-03-06
Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1106-2024·2024-03-06
MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure
MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1135-2024·2024-03-06
Medline recalls Centurion Laceration Trays for potential sterility defect
Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.
Product
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1060-2024·2024-03-06
AirLife Adult Manual Resuscitator Kits Recalled for Component Failure
Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1124-2024·2024-03-06
Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
Product
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1205-2024·2024-03-06
Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive
Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.
Product
Colonoscope, Model Number CF-H180AL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2024·2024-03-06
IdentiTi ALIF surgical graft bolts recalled due to intraoperative breakage
Alphatec Spine recalls IdentiTi ALIF graft bolts after reports of breakage during implantation. Approximately 12,777 devices are affected worldwide.
Product
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1195-2024·2024-03-06
Integra Cranial Access Kit: Sterile Packaging Integrity Failure
Integra LifeSciences is recalling 23 units of the Cranial Access Kit due to defects in sterile packaging that may compromise product sterility. Units were distributed worldwide.
Product
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2024·2024-03-06
Cranial Access Kit recalled due to sterile packaging integrity defect
Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.
Product
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2024·2024-03-06
Integra cranial access kit recalled for sterile packaging failure
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
Product
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2024·2024-03-06
Colonoscope Model CF-HQ190L Recalled Due to Missing Protective Adhesive
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number CF-HQ190L.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2024·2024-03-06
Rebstock Holding Rod for Fixation May Move Uncontrollably
The Rebstock Holding rod for fixation, a surgical instrument, may move or twist uncontrollably during use, potentially compromising patient safety if the movement transfers to attached equipment.
Product
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1219-2024·2024-03-06
Hip Implant Component Mislabeled With Wrong Insert Type on Packaging
LINK BiMobile hip implant liners are being recalled because packaging incorrectly identifies the insert type as F instead of G. This labeling error could delay surgery or result in the wrong component being used.
Product
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2024·2024-03-06
Olympus Colonoscope Recall: Missing Protective Adhesive in 47 Units
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number PCF-H190DL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2024·2024-03-06
Colonoscope Model CF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.
Product
Colonoscope, Model Number CF-Q180AL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2024·2024-03-06
Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Product
Colonoscope, Model Number PCF-Q180AL.
Category
Medical Device
Distribution
Distributed nationwide

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7101–7125 of 13683