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

5176–5200 of 13512

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
HighFDA (Devices)·Z-3100-2024·2024-09-18
Medical device diagnostic test shows measurement bias in certain samples
Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.
Product
Atellica IM 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: 10995490
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3051-2024·2024-09-18
Medline Convenience Kits Recalled Due to Plastic Syringe Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Num
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3072-2024·2024-09-18
Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing
Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.
Product
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3056-2024·2024-09-18
Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.
Product
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3037-2024·2024-09-18
Medline Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose patient safety risks. The recall affects multiple pack types distributed worldwide.
Product
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3021-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Plastic Syringe Quality Issues
Medline is recalling multiple convenience kits containing defective plastic syringes that may leak or break, posing potential patient health risks. The defective syringes were identified through an FDA Safety Alert issued March 19, 2024.
Product
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3038-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Defects
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.
Product
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3050-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Quality Defects
Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.
Product
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6)
Category
Medical Device
Distribution
0 states
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-2989-2024·2024-09-18
Medline Spinal Block Syringes Recalled for Quality Defects
Medline is recalling spinal block syringes due to leaks, breakage, and other quality issues identified in an FDA safety alert. The recalled lots have worldwide distribution and span from 2019 to 2023.
Product
Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3007-2024·2024-09-18
Medline Medical Convenience Kits with Defective Plastic Syringes Recalled
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3017-2024·2024-09-18
Medline Convenience Kits Recalled for Syringe Leaks and Breakage
Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.
Product
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3124-2024·2024-09-18
Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines
Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.
Product
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3036-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Product
Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3071-2024·2024-09-18
Anesthesia Turnover Kit with Non-Sterile Mastisol Component Recalled
Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
Product
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3092-2024·2024-09-18
Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
Product
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
Category
Medical Device
Distribution
Distributed nationwide
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-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-3045-2024·2024-09-18
Medline medical convenience kits recalled for defective plastic syringes
Medline is recalling medical convenience kits with plastic syringes affected by quality defects including leaks and breakage. The defective syringes may pose risks to patient safety during medical procedures.
Product
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2993-2024·2024-09-18
Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.
Product
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT
Category
Medical Device
Distribution
0 states
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-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-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

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5176–5200 of 13512