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

7826–7850 of 39968

SevereFDA (Devices)·Z-1095-2024·2024-03-06
Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1064-2024·2024-03-06
AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation
Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.
Product
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1129-2024·2024-03-06
Medical maintenance flush kits recalled for potential sterility defect
Medline Industries is recalling Centurion maintenance flush and blood draw kits due to potential sterility issues in component solutions. Affected lot numbers are 2022031480 and 2022041180.
Product
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1132-2024·2024-03-06
Medline Centurion surgical trays and kits recalled for potential non-sterile solutions
Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.
Product
Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1103-2024·2024-03-06
Medline surgical kits and trays recalled for sterility defects
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1097-2024·2024-03-06
Medline Medical Kits and Trays Recalled for Non-Sterile Solutions
Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK,
Category
Medical Device
Distribution
Distributed nationwide
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-1117-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.
Product
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1058-2024·2024-03-06
AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation
Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1122-2024·2024-03-06
Medline kits and trays recalled for potential lack of sterility
Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1105-2024·2024-03-06
Medline Dialysis Kits Recalled for Potential Sterility Defects
Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.
Product
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
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-1138-2024·2024-03-06
Medline circumcision surgical kits recalled for sterility concerns
Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.
Product
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1124-2024·2024-03-06
Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
Product
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2024·2024-03-06
Medline Prep Kits Recalled Due to Non-Sterile Components
Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
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-1128-2024·2024-03-06
Medline Suction Catheter Kits Recalled for Potential Sterility Defects
Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1108-2024·2024-03-06
Medline Instrument Trays Recalled for Potential Sterility Defect
Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1162-2024·2024-03-06
Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, 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-1106-2024·2024-03-06
MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure
MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1094-2024·2024-03-06
Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk
Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.
Product
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1092-2024·2024-03-06
MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure
MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1057-2024·2024-03-06
AirLife Adult Manual Resuscitator units recalled for component failure
Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to hypoxia or death.
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1135-2024·2024-03-06
Medline recalls Centurion Laceration Trays for potential sterility defect
Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.
Product
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
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

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7826–7850 of 39968