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

29826–29850 of 40325

HighFDA (Devices)·Z-1982-2016·2016-06-22
Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 438 BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1969-2016·2016-06-22
Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of hemolysis during blood sampling.
Product
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2016·2016-06-22
Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk During Blood Sampling
Navilyst Medical is recalling 210 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2016·2016-06-22
Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.
Product
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2016·2016-06-22
Navilyst Medical Recalls Vaxcel PICC Catheters with PASV Valve
Navilyst Medical is recalling Vaxcel PICC catheters with PASV valves manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.
Product
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1985-2016·2016-06-22
Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology
Navilyst Medical is recalling 445 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1991-2016·2016-06-22
CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires
CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.
Product
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1952-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch sterile barrier system.
Product
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1992-2016·2016-06-22
Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues
Med Tec Inc is recalling specific versions of Protura Robotic Couch System Software because non-sub-millimeter positioning is inconsistent with settings in split shift mode.
Product
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1963-2016·2016-06-22
Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.
Product
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1955-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.
Product
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2016·2016-06-22
Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2016·2016-06-22
Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure
Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.
Product
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1958-2016·2016-06-22
Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.
Product
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1998-2016·2016-06-22
Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect
Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.
Product
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1962-2016·2016-06-22
Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.
Product
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1953-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterility Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.
Product
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1976-2016·2016-06-22
Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela PICC catheters because they lack a manufacturing change that reduces the risk of hemolysis during blood sampling.
Product
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2000-2016·2016-06-22
Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts
Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.
Product
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2002-2016·2016-06-22
Datascope Small Patient ECC Pack Recalled for Excess Endotoxin
Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.
Product
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1988-2016·2016-06-22
Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology
Navilyst Medical is recalling specific BioFlo Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.
Product
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterility Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch barrier system.
Product
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1997-2016·2016-06-22
Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts
Siemens is recalling one Biograph mCT scanner because unwelded bolts may cause the cover to fall during service.
Product
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1977-2016·2016-06-22
Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2016·2016-06-22
Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts
Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.
Product
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

29826–29850 of 40325