Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

38101–38125 of 40449

ModerateFDA (Devices)·Z-1628-2013·2013-07-10
Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise
Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2013·2013-07-10
SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating
SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.
Product
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2013·2013-07-10
ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color
ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.
Product
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1659-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.
Product
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1645-2013·2013-07-10
Braemar Recalls Lithium Thionyl Battery Packs for ER920W Event Recorders
Braemar Inc. is recalling 10,785 lithium thionyl battery packs used with ER920W wireless event monitors following a battery incident that caused no patient injury.
Product
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1639-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter
Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.
Product
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1637-2013·2013-07-10
TPS Micro Reciprocating Rasp Recalled Due to Compromised Sterile Seal
Surgical Instrument Service And Savings, Inc. is recalling four units of TPS Micro Reciprocating Small Tear Cross Cut Rasps because the sterile barrier seal may be compromised.
Product
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1627-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1632-2013·2013-07-10
Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal
Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.
Product
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1626-2013·2013-07-10
Surgical Suture Recall Due to Compromised Sterile Barrier Seal
Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1642-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Phacofragmentation System Tips
Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.
Product
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1634-2013·2013-07-10
Surgical Instrument Recall Due to Compromised Sterile Seal
Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasps because the sterile seal may be compromised, allowing the product to fall out of the pouch.
Product
Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1623-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Carpal Tunnel Release Blades
Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially allowing product to fall out of the pouch.
Product
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release…
Category
Medical Device
Distribution
Distributed nationwide
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

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38101–38125 of 40449