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

4276–4300 of 39987

HighFDA (Devices)·Z-1431-2025·2025-04-02
Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect
Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.
Product
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,ME
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2025·2025-04-02
Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects
Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.
Product
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2025·2025-04-02
Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment
A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 units distributed nationwide are affected.
Product
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2025·2025-04-02
Medline surgical procedure kits recalled for syringe leaks and breakage
Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2025·2025-04-02
Baxter Operating Table Column Software Issue Limits Emergency Mode Function
Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.
Product
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1432-2025·2025-04-02
Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.
Product
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1412-2025·2025-04-02
Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment
Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.
Product
Baxter Mobile column TruSystem 7500, Product Code 1717023
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1434-2025·2025-04-02
Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1433-2025·2025-04-02
NexGen LPS Flex knee prosthesis recalled for labeling inconsistency
Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.
Product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1285-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk
Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1288-2025·2025-03-26
Smiths Medical ProPort Implantable Port Plastic Housing May Separate
The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.
Product
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1278-2025·2025-03-26
Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect
Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1277-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System Recalled
Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.
Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1280-2025·2025-03-26
Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect
Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1287-2025·2025-03-26
Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation
Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.
Product
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1286-2025·2025-03-26
Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.
Product
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1283-2025·2025-03-26
Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation
Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1284-2025·2025-03-26
Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk
Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1279-2025·2025-03-26
Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1281-2025·2025-03-26
Smiths Medical ProPort Implantable Port Risk of Component Separation
Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1282-2025·2025-03-26
Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect
Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1404-2025·2025-03-26
CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Product
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2025·2025-03-26
Laceration Tray Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide

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4276–4300 of 39987