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.

20251–20275 of 21633

ModerateFDA (Devices)·Z-1657-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low Motor RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may operate at lower than expected speeds in free-running conditions.
Product
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1643-2013·2013-07-10
Surgical Instrument Service Recalls ENDOPATH Trocars Due to Compromised Sterile Seals
Surgical Instrument Service and Savings, Inc. is recalling 259 ENDOPATH trocars and accessories because compromised sterile seals may allow product to fall out of the pouch.
Product
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1635-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Orthopedic Drill Bits
Surgical Instrument Service And Savings, Inc. is recalling 10 orthopedic drill bits because the sterile barrier seal was compromised, allowing product to fall out of the pouch.
Product
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1660-2013·2013-07-10
Merit Medical Systems Recalls Custom Angio Kits Due to Sterility Concerns
Merit Medical Systems is recalling 134 custom angio kits because a missing seal may compromise the sterility of the hand controller sheaths.
Product
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1653-2013·2013-07-10
Penlon Delta Anesthetic Vaporizer Recalled for Manual Clarity Improvements
Penlon Ltd is recalling Delta Vaporizers to update the User Manual with clearer installation and pre-use check instructions.
Product
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1624-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 15 Suture Instruments
Surgical Instrument Service And Savings, Inc. is recalling 15 suture instruments because compromised seals may allow the sterile barrier to fail.
Product
- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1616-2013·2013-07-10
GE Healthcare Recalls Innova 3100 and 4100 Fluoroscopic Systems
GE Healthcare is recalling Innova 3100 and 4100 systems due to a potential safety issue involving temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration.
Product
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1633-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 907 Arthroscopic Instruments
Surgical Instrument Service And Savings, Inc. is recalling 907 arthroscopic instruments because compromised sterile seals may allow product to fall out of the pouch.
Product
- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1636-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Suture Graspers Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling two lots of IDEAL Suture Graspers because the sterile barrier seal may be compromised, allowing the product to fall out of the pouch.
Product
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1665-2013·2013-07-10
SpineFrontier Recalls S-LIFT Inserter Outer Sleeve Due to Fit Issue
SpineFrontier, Inc. is recalling 12 S-LIFT Inserter Outer Sleeves because the handle hole is too small to fit the assembly.
Product
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1658-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.
Product
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1638-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Compression Sleeves Due to Seal Failure
Surgical Instrument Service And Savings, Inc. is recalling 229 units of compression sleeves and garments because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1625-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 13 Medical Devices Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices because compromised seals may allow products to fall out of sterile pouches.
Product
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1644-2013·2013-07-10
Harmonic ACE Curved Shear Recall Due to Compromised Sterile Seal
Surgical Instrument Service And Savings, Inc. is recalling Harmonic ACE Curved Shears because the sterile seal may be compromised, allowing the product to fall out of the pouch.
Product
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1641-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Arthroscopic Cannulas Due to Seal Defect
Surgical Instrument Service And Savings, Inc. is recalling 73 arthroscopic cannulas because a compromised seal may allow the product to fall out of the sterile pouch.
Product
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1631-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 30 Surgical Instrument Motors and Accessories
Surgical Instrument Service And Savings, Inc. is recalling 30 surgical instrument motors and accessories because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-622-2013·2013-07-03
INK-EEZE Tattoo Numbing Spray Recalled for Lack of FDA Approval
Indelicare LLC is recalling INK-EEZE Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-1599-2013·2013-07-03
ConBio Recalls Multilite Dye Handpieces for Display Identification Inconsistency
ConBio is recalling 12 Multilite Dye Handpieces for the RevLite SI Laser due to an electronic display inconsistency that may confuse users.
Product
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-623-2013·2013-07-03
Baxter Recalls 0.9% Sodium Chloride Injection Due to Barcode Labeling Error
Baxter Healthcare is recalling 317,280 bags of 0.9% Sodium Chloride Injection because the barcode may incorrectly identify the product as 100 mL instead of 50 mL.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1610-2013·2013-07-03
Baxter Recalls Infusor Devices Due to Potential Leaks at Luer Connections
Baxter Healthcare is recalling specific Infusor devices because of increased complaints about leaks at the distal male Luer and Luer cap.
Product
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2013·2013-07-03
U-systems Recalls Soma v Automated Breast Ultrasound System for Labeling Error
U-systems Inc is recalling three Soma v Automated Breast Ultrasound Systems because the user manuals incorrectly list the indication for use of a different product model.
Product
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Category
Medical Device
Distribution
2 states
ModerateFDA (Food)·F-1550-2013·2013-07-03
Norpac IQF Chopped Spinach Recalled for Elevated Cadmium Levels
Norpac Foods is recalling IQF Chopped Spinach due to elevated cadmium levels. The product was distributed in California, Missouri, Oregon, and Wisconsin.
Product
FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: "***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen…
Category
Food
Distribution
4 states
ModerateFDA (Devices)·Z-1567-2013·2013-07-03
GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues
GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.
Product
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1585-2013·2013-07-03
GE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss
GE Healthcare is recalling 9 units of Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because a specific configuration can cause loss of free-text data in microbiology results.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-1551-2013·2013-07-03
Enzyme Solutions Formula 29 Recalled for Labeling Error
Enzyme Formulations, Inc. is recalling 256 bottles of Enzyme Solutions Formula 29 due to a manufacturing labeling error that resulted in incorrect contents.
Product
Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.
Category
Food
Distribution
28 states