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

5326–5350 of 13666

HighFDA (Devices)·Z-3078-2024·2024-09-18
Multiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
Sol-Millennium Medical is recalling multiple syringe models because the distributed products are substantially different from FDA-cleared specifications, with major changes to the intended use.
Product
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Ex
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2986-2024·2024-09-18
Medline medical convenience kits recalled due to syringe quality defects
Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.
Product
Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2982-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling medical convenience kits due to quality issues in plastic syringes, including leaks and breakage that may affect patient safety. Affected products include tracheostomy kits and airway packs distributed worldwide.
Product
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DY
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2994-2024·2024-09-18
Medline Vascular IVC Filter Placement Kits Recalled for Syringe Defects
Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.
Product
Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2975-2024·2024-09-18
HeNe Laser System Allows Key Removal While Operating
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
Product
25-LHP-828, HeNe Laser System, 35 mW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3116-2024·2024-09-18
Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss
Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2998-2024·2024-09-18
Medline surgical convenience kits recalled due to defective plastic syringes
Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Num
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3069-2024·2024-09-18
Sterile Surgical Kit Contains Non-Sterile Component Without Label
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
Product
CRANIOTOMY PACK, Pack Number DYNJ46552O
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3047-2024·2024-09-18
Medline convenience kits recalled for syringe leaks and breakage defects
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
Product
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Nu
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3010-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3041-2024·2024-09-18
Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3022-2024·2024-09-18
Medline Convenience Kits with Defective Syringes Recalled Due to Leaks and Breakage
Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.
Product
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3040-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Plastic Syringe Defects
Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures and may pose risks to patient health.
Product
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3008-2024·2024-09-18
Medline Esophagectomy Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Industries recalls esophagectomy convenience kits containing plastic syringes with leaks and breakage issues. The defects may pose a risk to patient health during surgical procedures.
Product
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3019-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Defective Syringes
Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.
Product
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Numbe
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3103-2024·2024-09-18
Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
Product
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3112-2024·2024-09-18
Medline Suction Liners Recalled Due to Potential Loss of Suction
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3098-2024·2024-09-18
Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels
Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.
Product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3079-2024·2024-09-18
FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
Product
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3073-2024·2024-09-18
Medtronic InterStim Handset May Fail to Pair with Communicator
Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.
Product
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3094-2024·2024-09-18
Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect
Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.
Product
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3120-2024·2024-09-18
Medline recalls surgical convenience kits in Class II recall
Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2943-2024·2024-09-11
Trilogy Evo Ventilator Software Update for Identified Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.
Product
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2942-2024·2024-09-11
Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.
Product
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2721-2024·2024-09-11
Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk
Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Category
Medical Device
Distribution
4 states

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5326–5350 of 13666