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

5126–5150 of 13449

HighFDA (Devices)·Z-3093-2024·2024-09-18
Medline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal
Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.
Product
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3077-2024·2024-09-18
SOL-M Syringes with eccentric tips recalled for regulatory non-compliance
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Product
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3107-2024·2024-09-18
Medline Surgical Suction Liners Recalled for Potential Loss of Suction
Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3118-2024·2024-09-18
Medline semi-rigid suction liners recalled for potential loss of suction
Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3023-2024·2024-09-18
Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
Product
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) L
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3031-2024·2024-09-18
Medical convenience kits with plastic syringes recalled for leaks and breakage
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.
Product
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2999-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.
Product
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2997-2024·2024-09-18
Medline recalls medical convenience kits with defective plastic syringes
Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.
Product
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;
Category
Medical Device
Distribution
0 states
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-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-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
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-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-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-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
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
SevereFDA (Devices)·Z-2690-2024·2024-09-11
Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk
Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.
Product
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2944-2024·2024-09-11
Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.
Product
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2965-2024·2024-09-11
Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Product
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2980-2024·2024-09-11
Beckman Power Express Centrifuge Sample Holder May Detach During Operation
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
Product
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2979-2024·2024-09-11
Power Express PE Centrifuge adhesive joint failure may cause component detachment
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
Product
PE Centrifuge, REF: B36365, a component of the Power Express
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2945-2024·2024-09-11
Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2978-2024·2024-09-11
Medical Device Sample Holder Recalled for Adhesive Joint Failure
Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.
Product
Power Express, REF B90918
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

5126–5150 of 13449