State

Hawaii product recalls

20,364 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Hawaii consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12376–12400 of 20364

HighFDA (Devices)·Z-2174-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Seam Barrier Defects
Medline is recalling ultrasound probe cover kits with sterile gel due to inadequate seam barriers that may compromise sterility during diagnostic procedures. Approximately 8,974 units distributed worldwide from 2017 to 2023 are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2197-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate barrier at seams
Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling 173,449 sterile probe cover kits due to inadequate seam barriers that may compromise sterility. The affected units were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling multiple probe cover kits used in diagnostic ultrasound and vascular access procedures due to inadequate barriers at the seams. No illnesses or injuries have been reported.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2203-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline Industries is recalling 1,240 Probe Cover Kits used in diagnostic ultrasound procedures. The covers may have inadequate barriers at the seams, potentially compromising sterility during medical procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2023·2023-07-26
FDA Recalls Medline Probe Cover Kits Due to Seam Defects
Medline is recalling probe cover kits used in diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams, which could compromise sterility during procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling 770,147 ultrasound probe cover kits worldwide due to inadequate barriers at the seams. The defect could allow contamination during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Nu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2023·2023-07-26
RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling ultrasound probe cover kits for an inadequate barrier at the seams that could compromise sterility. The recall affects 1,130 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2178-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2023·2023-07-26
Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance
SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.
Product
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2195-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling probe cover kits containing sterile ultrasound gel due to inadequate barriers at the seams, which may compromise sterility during diagnostic ultrasound procedures. The recall affects 2,590 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0923-2023·2023-07-26
Tizanidine Tablets Recalled Nationwide for Failed Dissolution Specification
Dr. Reddy's Laboratories is recalling Tizanidine 4 mg tablets nationwide because 24-month stability testing revealed dissolution specification failures. No illnesses or injuries have been reported.
Product
TIZANIDINE — TIZANIDINE (TIZANIDINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers
Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2023·2023-07-26
Medline probe cover kits recalled for inadequate seam barrier protection
Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect
Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling probe cover kits used in cardiac and vascular ultrasound procedures due to inadequate seam barriers. Over 3.7 million units were distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline is recalling 172,722 ultrasound probe cover kits due to inadequate barrier protection at the seams. The defect may compromise protective function during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2186-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling 14,848 ultrasound probe cover kits due to potentially inadequate barriers at the seams. The kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2023·2023-07-26
Infant Heel Warmer Recalled Due to Burst and Leaking
Cardinal Health is recalling 44,500 NovaPlus Infant Heel Warmers from lot V2S056 due to reports of bursting and leaking. Units were distributed nationwide.
Product
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS,
Category
Medical Device
Distribution
Distributed nationwide