Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

151–175 of 21557

ModerateFDA (Devices)·Z-2660-2026·2026-07-08
Power-Trialysis Dialysis Catheters Recalled Due to Manufacturing Defects
Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.
Product
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2668-2026·2026-07-08
Soft Tissue Biopsy Trays recalled due to deficient manufacturing practices
Bard Access Systems is recalling soft tissue biopsy trays (models 4380 Economy and 4382A) due to lidocaine ampoules being manufactured under deficient manufacturing practices.
Product
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2658-2026·2026-07-08
PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall
Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.
Product
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2641-2026·2026-07-08
ARTIS icono biplane medical imaging system detector lift malfunction
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
Product
ARTIS icono biplane. Model Number: 11327600.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2630-2026·2026-07-08
CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Product
CRE Pro Wireguided 15-18mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2664-2026·2026-07-08
PowerPICC Provena Catheters recalled for deficient manufacturing practices
Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.
Product
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2656-2026·2026-07-08
Poly Midline Catheters recalled due to manufacturing defects
Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Product
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline cathet
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2659-2026·2026-07-08
PowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
Product
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2655-2026·2026-07-08
Thoracentesis and Paracentesis Trays Recalled for Deficient Manufacturing
Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.
Product
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in re
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2026·2026-07-08
CRE Wireguided 8-10mm 240cm Medical Device Recall Notice
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Product
CRE Wireguided 8-10mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0657-2026·2026-07-08
Synjardy XR Tablets Recalled Due to Manufacturing Deviations
Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg due to manufacturing deviations involving incorrect detergent use and missing swab sampling.
Product
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-2657-2026·2026-07-08
DuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.
Product
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0696-2026·2026-07-08
vite20 Antifungal Cream recalled due to stability testing deviations
Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.
Product
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2026·2026-07-08
Terpenicol Antifungal Solution Recalled for CGMP Deviations
Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.
Product
TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2654-2026·2026-07-08
Medline 111 Gravity Set with Needle Free Y-Sites engineering sample recall
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
Product
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2669-2026·2026-07-08
Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation
Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.
Product
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2541-2026·2026-07-08
Medline Convenience Kits Recalled Due to Lidocaine Quality Issues
Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Product
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2673-2026·2026-07-08
Sterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2542-2026·2026-07-08
Medline Convenience Kits recalled for defective Lidocaine Ampules
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
Product
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2546-2026·2026-07-08
Medline Circumcision Trays recalled due to Lidocaine quality issues
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Product
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-1135-2026·2026-07-08
Dietary Supplement Vista MAX Recalled for Undeclared Yellow #5 Allergen
Vista MAX dietary supplement contains undeclared Yellow #5 dye. Consumers allergic to or sensitive to Yellow #5 should not consume the product.
Product
Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023
Category
Food
Distribution
0 states
ModerateFDA (Food)·H-1134-2026·2026-07-08
Dietary supplement Ocular Plus recalled for undeclared Yellow #5
L.A. Farmacia Natural is recalling Ocular Plus dietary supplement because it contains undeclared Yellow #5, which may affect consumers with tartrazine sensitivity or certain allergies.
Product
Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, CA 91504 UPC: PHF-C023
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-2635-2026·2026-07-08
CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.
Product
CRE Wireguided 12-15mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2666-2026·2026-07-08
PowerPICC Catheters recalled for deficient manufacturing practices
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Product
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2026·2026-07-08
Covidien Shiley Disposable Decannulation Plug product labeling error
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
Product
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884
Category
Medical Device
Distribution
Distributed nationwide