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.

9626–9650 of 22144

HighFDA (Devices)·Z-0179-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
Category
Medical Device
Distribution
Distributed nationwide
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-0147-2025·2024-10-30
Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues
Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.
Product
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0217-2025·2024-10-30
Baxter Operating Table TruSystem 7000 U14 Recalled for Battery Short-Circuit Risk
Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.
Product
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
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-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 (Drugs)·D-0017-2025·2024-10-30
Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities 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 71506-029-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2025·2024-10-30
Internal Defibrillation Paddles Recalled for Cracks and Separation
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
Product
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2025·2024-10-30
medex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect
Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.
Product
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0010-2025·2024-10-30
CADD Medication Cassette Reservoirs recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0219-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2025·2024-10-30
Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Product
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
Category
Medical Device
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-0203-2025·2024-10-30
Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring
Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.
Product
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0221-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error
Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Product
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0058-2025·2024-10-30
Juice Recall: Incomplete Pasteurization in Happy Moose Tropical Roots
Happy Moose Juice Tropical Roots is recalled due to incomplete pasteurization of certain bottles. Consumers should not consume products with lot number H240903-E and enjoy-by date 12/02/2024.
Product
Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0011-2025·2024-10-30
CADD Medication Cassette Reservoir Recalled for Weld Defect Risk
Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.
Product
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0024-2025·2024-10-30
Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
Product
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Category
Drug
Distribution
Distributed nationwide
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 (Food)·F-0063-2025·2024-10-30
SureLife Foods Paleo Bars recalled for undeclared gluten
SureLife Foods Paleo Bars labeled as gluten-free contain gluten above 20 ppm according to consumer advocacy group testing. Approximately 48,384 units were distributed in California and Oregon.
Product
Principal Display: SureLife Foods PALEO BARS, Net Wt. 14 oz. (392 g.)- 14 ct. individually wrapped bars (28 g. each) Certified Gluten Free, Certified Paleo Loaed with: Almonds, Honey, Shredded Coconut, Pumpkin Seeds, Brazil Nuts, Chia Seeds & More! Back Display: Ingredients:
Category
Food
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-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