PlainRecalls

2016 Recalls

8,148 recalls · Page 145 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 163 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2016.

On this page of 50 records, severity classification shows 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 10 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2016 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Mammomat Inspiration with Tomosynthesis functionality

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily f…

Hospira Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastr…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, C…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 2, 2016

VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular ne…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system

Olympus Scientific Solutions Americas

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connector…

Centurion Medical Products Corporation

FDA Devices Moderate Mar 2, 2016

CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED),…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Pr…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating ch…

Medtronic Neuromodulation

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2016 with 2015 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA — consumer product and vehicle recall feeds for 2016