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.

5876–5900 of 21595

ModerateFDA (Devices)·Z-1590-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect
ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.
Product
REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1586-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect
ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.
Product
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2021·2021-05-19
ICU Medical Recalls Bag Spike Adapters Due to Molding Defect
ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1569-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage
ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.
Product
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateUSDA FSIS·PHA-05142021-01·2021-05-14
USDA Issues Public Health Alert for Ineligible Frozen Fish Imported from Brazil
USDA FSIS issued a public health alert for approximately 165 pounds of frozen fish imported from Brazil, a country ineligible to export these products to the U.S.
Product
FSIS Issues Public Health Alert for Ineligible Siluriformes Products Imported From Brazil
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1519-2021·2021-05-12
Oto Med Recalls Sheehy Bone Dust Collectors Due to Packaging Defects
Oto Med Inc is recalling 13,335 Sheehy Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.
Product
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2021·2021-05-12
LeMaitre Vascular Recalls LeverEdge Contrast Injectors Due to Packaging Particulates
LeMaitre Vascular is recalling 616 LeverEdge Contrast Injectors because particulates in the packaging foam could contaminate the sterile field.
Product
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1524-2021·2021-05-12
DJO EMPOWR KNEE Femoral Sizer Recalled Due to Incorrect Assembly
Encore Medical is recalling 16 DJO EMPOWR KNEE Femoral Sizers because incorrect assembly caused the size-indicating windows to face the wrong direction.
Product
DJO EMPOWR KNEE Femoral Sizer
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1532-2021·2021-05-12
Medtronic Abre Venous Self-expanding Sent System Recall for Incorrect Size Labeling
Medtronic is recalling 23 Abre Venous Self-expanding Sent Systems because the device size is incorrectly printed on the device itself, though the packaging is labeled correctly.
Product
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1525-2021·2021-05-12
Medtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error
Medtronic is recalling implantable pulse generators because a longevity estimation error may occur in early device life when specific pacing vectors are programmed.
Product
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureSca
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0479-2021·2021-05-12
Natrol Melatonin 3 mg Tablets Recalled for Mislabeling as ALA 300 mg
Natrol LLC is recalling one lot of Melatonin 3 mg tablets that were mislabeled as ALA 300 mg capsules. The recall covers 12,740 units distributed across multiple US states and international locations.
Product
Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol LLC. Chatsworth, CA 91311 USA
Category
Drug
Distribution
36 states
ModerateFDA (Devices)·Z-1521-2021·2021-05-12
Oto Med Recalls SpineX Bone Dust Collectors Due to Sterile Pouch Defects
Oto Med Inc is recalling 415 SpineX Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.
Product
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0365-2021·2021-05-12
Hand Sanitizer Recalled for Packaging Resembling Drinking Water Bottles
PNHC, LLC. is recalling 139,806 bottles of Heal The World hand sanitizer because the packaging resembles drinking water bottles.
Product
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-1528-2021·2021-05-12
Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error
Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.
Product
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1520-2021·2021-05-12
Oto Med Recalls Bone Dust Collectors Due to Sterile Pouch Defects
Oto Med Inc is recalling 5,092 Grace Medical Cox Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.
Product
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1527-2021·2021-05-12
Medtronic Programmers Recalled for Longevity Estimation Error
Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.
Product
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0358-2021·2021-05-12
FDA Recalls Acetaminophen in Health Kits Due to Labeling Error
A-S Medication Solutions is recalling Health Essentials Kits containing Acetaminophen 500mg tablets. The bottles were incorrectly labeled with prescription drug labels instead of OTC labels.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1511-2021·2021-05-05
Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet
DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab may fail. The recall covers units distributed in the US and several international countries.
Product
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1507-2021·2021-05-05
Datascope Cardiosave Rescue IABP Recalled for Cybersecurity Vulnerabilities
Datascope Corp. is recalling Cardiosave Rescue IABP units due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.
Product
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1489-2021·2021-05-05
Ortho-Clinical VITROS Black Reference Slides Recalled for Mislabeling
Ortho-Clinical Diagnostics is recalling VITROS Black Reference Slides incorrectly labeled as White Reference Slides, which may cause analyzer delays.
Product
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1495-2021·2021-05-05
Siemens Artis zee X-Ray System Recalled for Cabling Abrasion
Siemens Medical Solutions is recalling 772 Artis zee ceiling-interventional Fluoroscopic X-Ray Systems due to increased cabling abrasion that may limit functionality and disrupt clinical treatment.
Product
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1510-2021·2021-05-05
Smith & Nephew Recalls Mislabeled CANNU-Flex SILK Interference Screws
Smith & Nephew is recalling CANNU-Flex SILK Interference Screws because some boxes were mislabeled, containing 6mm x 20mm screws instead of the labeled 6mm x 30mm size.
Product
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1501-2021·2021-05-05
Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect
Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.
Product
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-1486-2021·2021-05-05
Cardiac Assist Recalls Incorrectly Packaged Protek Solo Venous Dilator Sets
Cardiac Assist, Inc. is recalling 13 Protek Solo Venous Dilator Sets due to incorrect packaging discovered in finished goods.
Product
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1493-2021·2021-05-05
Cytocell Recalls Chromosome X Alpha-Satellite Probes Due to Cross-Reactivity
Cytocell Ltd. is recalling 89 Chromosome X Alpha-Satellite probes because users may observe additional signals at 9q34, contradicting the insert.
Product
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Category
Medical Device
Distribution
Distributed nationwide