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

37526–37550 of 40449

HighFDA (Devices)·Z-2245-2013·2013-09-25
Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue
Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
Product
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2233-2013·2013-09-25
Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.
Product
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2013·2013-09-25
Tornier Recalls Aequalis Reversed II and Fracture Impactors
Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.
Product
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.…
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2225-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2013·2013-09-25
Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.
Product
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2230-2013·2013-09-25
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2237-2013·2013-09-25
Smith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.
Product
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2013·2013-09-25
Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in the primary pouches may breach the sterile barrier.
Product
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2013·2013-09-25
GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue
GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.
Product
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2204-2013·2013-09-25
Camlog USA Recalls Uncleared Dental Implant Abutments in Four States
Camlog USA is recalling one unit of a CONELOG Titanium Base dental implant abutment because it was not cleared for sale or use in the United States.
Product
C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2259-2013·2013-09-25
Kerr Recalls NX3 Try-In Gel Due to Material Mismatch
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.
Product
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2207-2013·2013-09-25
Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.
Product
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2206-2013·2013-09-25
Camlog USA Recalls Uncleared Dental Implant Abutments
Camlog USA is recalling three units of CONELOG Titanbasis CAD/CAM titanium base abutments because the product was not cleared for sale or use in the United States.
Product
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2203-2013·2013-09-25
Camlog USA Recalls Uncleared Dental Implant Abutments in Four States
Camlog USA is recalling two units of CONELOG Titanium Base CC dental implant abutments because the product was not cleared for sale or use in the United States.
Product
C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2258-2013·2013-09-25
Spine Smith VisuALIF PEEK Block Recall Due to Potential Sizing Mislabeling
Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.
Product
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2198-2013·2013-09-25
Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues
Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.
Product
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2211-2013·2013-09-25
Implantech Recalls Terino Square Chin-Style II-Medium Implants
Implantech Associates Inc is voluntarily recalling 8 units of Terino Square Chin-Style II-Medium implants because they do not meet dimensional requirements.
Product
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2208-2013·2013-09-25
Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.
Product
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2197-2013·2013-09-25
Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits
Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.
Product
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2218-2013·2013-09-25
Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in the primary pouches may breach the sterile barrier.
Product
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2253-2013·2013-09-25
GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure
GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.
Product
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2205-2013·2013-09-25
Camlog Dental Implant Abutments Recalled for Lack of FDA Clearance
Camlog USA is recalling six dental implant abutments because they were not cleared for sale or use in the United States.
Product
C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2254-2013·2013-09-25
Access Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters
Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.
Product
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2212-2013·2013-09-25
Zeppessis Reprocessed Manifolds Recalled for Lack of FDA Clearance
Zeppessis Reprocessing is recalling reprocessed single-use manifolds for Stryker Neptune systems because they lack FDA 510(k) clearance and a validated cleaning protocol.
Product
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical…
Category
Medical Device
Distribution
4 states

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37526–37550 of 40449