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

4151–4175 of 39948

ModerateFDA (Devices)·Z-1563-2025·2025-04-23
Welch Allyn Connex Spot Monitor blood pressure cuffs undeclared natural rubber
Baxter Healthcare is recalling certain Welch Allyn Connex Spot Monitor reusable blood pressure cuffs worldwide because packaging contains an undeclared natural rubber band that may trigger allergic reactions in sensitive individuals.
Product
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-M
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1606-2025·2025-04-23
Medline Convenience Kit Skin Lesion Set Potential Seal Defect
Medline is recalling its Skin Lesion Set convenience kits due to potential open or weak seals on breather pouches used for packaging. The compromised seals may affect the sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1613-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Open Breather Pouches
Medline Industries is recalling 706 units of various sterile convenience kits used for gynecological and other procedures due to potential open or weak seals on breather pouches. The packaging defect could affect product sterility.
Product
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1567-2025·2025-04-23
Welch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn DuraShock Aneroid Gauge Sets with reusable blood pressure cuffs due to undeclared natural rubber band in the packaging. This poses a risk to individuals with rubber allergies.
Product
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1576-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates
Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1572-2025·2025-04-23
ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.
Product
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1602-2025·2025-04-23
Sterile convenience kits recalled for potentially weak breather pouch seals
Medline Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.
Product
Refer to RES
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1597-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Open Breather Pouches
Medline Industries is recalling select sterile convenience kits because purchased breather pouches used for packaging may have open or weak seals, potentially compromising the sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-IC
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1571-2025·2025-04-23
ID NOW COVID-19 2.0 Point-of-Care Test Device Recall
Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.
Product
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Open Breather Pouches
Medline Industries is recalling three models of sterile convenience kits used for arthroscopy procedures due to potential open or weak seals on the breather pouches used for packaging.
Product
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1573-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to the product instructions.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1577-2025·2025-04-23
Maquet VH-3010 Power Supply Recalled for Inadequate Heating Function
Maquet Cardiovascular is recalling 110 units of the VH-3010 Power Supply due to an incorrect resistor that may prevent the HemoPro 2 harvesting tool jaws from heating adequately.
Product
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1543-2025·2025-04-16
Stimulation RC Clinician Programmer Application Software Communication Issue
The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.
Product
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1456-2025·2025-04-16
Medline medical procedure kits with Medtronic Aortic Root Cannula recalled
Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1512-2025·2025-04-16
Hippo 072 Aspiration System recalled for distal tip detachment risk
Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.
Product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1505-2025·2025-04-16
Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.
Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1457-2025·2025-04-16
Medline Medical Procedure Kits with Aortic Root Cannula Recalled
Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1459-2025·2025-04-16
Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1458-2025·2025-04-16
Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1545-2025·2025-04-16
BD Pyxis automated dispensing cabinets recalled for software dosing bug
CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.
Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1548-2025·2025-04-16
Medline ReNewal ENT Coblator II PROcise XP Wand recalled
Medline has recalled 315 units of the ReNewal ENT Coblator II PROcise XP Wand nationwide because the drip chamber may disconnect from the saline line tubing under tension.
Product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2025·2025-04-16
Medline ReNewal Coblator II Evac 70 Xtra Plasma Wand Disconnection Risk
Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand due to risk that drip chambers may disconnect from the saline line tubing under tension.
Product
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1547-2025·2025-04-16
Medline ReNewal Coblator II ENT Device Drip Chamber Disconnection Risk
Medline is recalling 20 units of ReNewal Coblator II ENT devices because drip chambers may disconnect from saline tubing under tension, potentially disrupting fluid delivery during procedures.
Product
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1537-2025·2025-04-16
Stryker Blueprint Mixed Reality Instrument Check Block Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.
Product
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1532-2025·2025-04-16
Omnicell IVX Station Reconstitution Transfer Sets Recall
Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.
Product
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
Category
Medical Device
Distribution
1 state

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4151–4175 of 39948