Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6801–6825 of 52962

HighFDA (Drugs)·D-0020-2025·2024-10-30
FDA Recalls NORepinephrine Injection Due to Manufacturing Violations
Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.
Product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0079-2025·2024-10-30
Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet
Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.
Product
Amingo. OUS only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2025·2024-10-30
Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information
Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.
Product
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Category
Medical Device
Distribution
11 states
HighFDA (Drugs)·D-0016-2025·2024-10-30
Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2025·2024-10-30
Medline catheter procedure kits recalled for potential sterility compromise
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Product
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2025·2024-10-30
Medline convenience kits recalled for potential use of non-sterile product
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
Product
Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0057-2025·2024-10-30
Sour Charlie bread recalled for undeclared wheat allergen
Salt City Baking Company recalls Sour Charlie bread due to missing ingredient labeling. Product contains wheat flour but was distributed without an Ingredients Statement, posing a risk to wheat-allergic consumers.
Product
Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a cardboard box and was not sold to consumers. Product was not labeled with a best by/exp date but recalling firm s
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0146-2025·2024-10-30
Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue
Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.
Product
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0167-2025·2024-10-30
Medline chest tube insertion tray may contain non-sterile equipment due to breached seal
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Product
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2025·2024-10-30
TranStar Disposable Pressure Transducer Kit recalled for manufacturing defect
Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.
Product
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0213-2025·2024-10-30
Baxter Operating Table TruSystem 7000 recalled for electrical hazard
Baxter is recalling 1,077 TruSystem 7000 operating tables worldwide due to electrical short-circuits and smoke emissions in battery connectors reported by customers.
Product
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0013-2025·2024-10-30
CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0204-2025·2024-10-30
Medex TranStar pressure monitoring sets recalled due to manufacturing defect
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
Product
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0018-2025·2024-10-30
ENT Medication Reservoirs Recalled for Weakened Weld Joint
Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.
Product
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0183-2025·2024-10-30
Medex TranStar ICP Pressure Monitoring Device Recalled Due to Manufacturing Defect
Smiths Medical is recalling the medex TranStar Single ICP Set because a manufacturing defect may cause inaccurate pressure monitoring, monitoring interruptions, or inability to zero the device.
Product
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0150-2025·2024-10-30
Medline Centurion Medical Procedure Kits Recalled for Sterility Risk
Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.
Product
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0182-2025·2024-10-30
medex TranStar Pressure Transducer Recall Due to Manufacturing Defect
Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Product
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0169-2025·2024-10-30
Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Sterility Risk
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0216-2025·2024-10-30
Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards
Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.
Product
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0162-2025·2024-10-30
Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging
Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.
Product
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2025·2024-10-30
Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect
Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.
Product
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0184-2025·2024-10-30
Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect
Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Product
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0163-2025·2024-10-30
Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk
Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2025·2024-10-30
Smiths Medical Arterial Kit recalled for pressure monitoring defect
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
Product
medex Arterial Kit 1/EA, Product Code REF MX7827
Category
Medical Device
Distribution
0 states