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

6001–6025 of 27364

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-1101-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Defects
Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1137-2024·2024-03-06
Centurion breast biopsy kits recalled due to potential sterility issues
Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.
Product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1131-2024·2024-03-06
Medline Centurion Eye Prep Kit Sterilization Defect Recall
Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.
Product
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1065-2024·2024-03-06
AirLife Manual Resuscitator recalled for broken components causing ventilation failure
Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1111-2024·2024-03-06
Medline Medical Device Kits Recalled for Potential Sterility Loss
Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1133-2024·2024-03-06
Medline Tracheostomy Care Trays Recalled for Sterility Issues
Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.
Product
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1114-2024·2024-03-06
Medline Port Removal Kits Recalled for Potential Sterility Loss
Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
Category
Medical Device
Distribution
Distributed nationwide
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-1164-2024·2024-03-06
Medtronic Duet External Drainage System catheter disconnection risk recalled
Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, 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
HighFDA (Devices)·Z-1215-2024·2024-03-06
Hip Implant System Recalled for Potential Incorrect Stem Orientation
United Orthopedic Corporation is recalling the USTAR II Hip System Press-Fit Curved Stem due to a potential risk that the implant curved stem may be oriented incorrectly. The FDA Class II recall affects 598 units.
Product
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417
Category
Medical Device
Distribution
9 states
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-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
HighFDA (Devices)·Z-1203-2024·2024-03-06
Integra Cranial Access Kit Recalled Due to Sterile Packaging Defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in sterile packaging that could compromise product sterility. The device is used for neurosurgical access to the brain.
Product
Ref No: INSHITHRZN / 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-1199-2024·2024-03-06
Integra Cranial Access Kit recall over sterile packaging defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in the sterile packaging that may compromise product sterility. Affects 30 units distributed worldwide.
Product
Ref No: INS7270 / 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-1212-2024·2024-03-06
Olympus colonoscope PCF-H190TL recalled for missing protective adhesive
Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.
Product
Colonoscope, Model Number PCF-H190TL.
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-1194-2024·2024-03-06
Integra Cranial Access Kit Recalled for Sterile Packaging Defect
Integra LifeSciences is recalling 27 units of its Cranial Access Kit due to defective sterile packaging that may compromise product sterility. The kits were distributed worldwide.
Product
Ref No: HITHSP04 / 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-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-1121-2024·2024-03-06
Medline Nursing Education Kits Recalled for Potential Lack of Sterility
Medline Industries recalls 844 units of nursing education kits and trays due to potential lack of sterility in Nurse Assist irrigation solution components. Products distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2024·2024-03-06
Bone plates and surgical screws distributed without FDA pre-market clearance
Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.
Product
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2024·2024-03-06
Colonoscope Model CF-HQ190I recalled for missing protective adhesive
Olympus is recalling certain repaired Model CF-HQ190I colonoscopes assembled without protective adhesive, which may cause equipment failure under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number CF-HQ190I.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2024·2024-03-06
Integra Cranial Access Kit Recalled for Defective Sterile Packaging
Integra LifeSciences is recalling 915 units of its Cranial Access Kit worldwide due to defective sterile packaging that may compromise product sterility. The header bags failed required packaging integrity testing.
Product
Ref No: INSHITHND / 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-1200-2024·2024-03-06
Integra Cranial Access Kit Recall Due to Sterile Packaging Defect
Integra LifeSciences is recalling the INS7280 Cranial Access Kit due to a packaging defect that may compromise product sterility. The recall affects 82 units distributed worldwide.
Product
INS7280 / 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-1213-2024·2024-03-06
Colonoscope Model PCF-HQ190L Recalled for Missing Protective Adhesive
Olympus is recalling 28 colonoscopes (Model PCF-HQ190L) due to missing adhesive that protects the device from vibration, temperature changes, and physical shock. The defect could cause device malfunction during procedures.
Product
Colonoscope, Model Number PCF-HQ190L.
Category
Medical Device
Distribution
Distributed nationwide

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6001–6025 of 27364