PlainRecalls

2016 Recalls

8,148 recalls · Page 137 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, 48 moderate, and 2 lower-severity recalls. The page references 12 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 23, 2016

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Pro-Dex Inc

FDA Devices Moderate Mar 23, 2016

Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POL…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A s…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEY…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIEC…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 7653…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee…

Zimmer Manufacturing B.V.

FDA Devices Low Mar 23, 2016

ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of a…

Collagen Matrix Inc

FDA Devices Low Mar 23, 2016

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the ant…

Volk Optical Inc

FDA Devices Moderate Mar 23, 2016

Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Mar 23, 2016

Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smoo…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (…

Deerfield Imaging

FDA Devices Moderate Mar 23, 2016

Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip a…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT.…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEM…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NA…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

CareFusion 303, Inc.

FDA Devices Moderate Mar 23, 2016

Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NA…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 C…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 3…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX C…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath …

Cordis Corporation

FDA Devices Moderate Mar 23, 2016

Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PREC…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SH…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

NuOSS Cancellous Intended for use in dental surgery.

Collagen Matrix Inc

FDA Devices Moderate Mar 23, 2016

Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION …

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Pilling Modular Verres Body/Obturator, Product Code 140880

Teleflex Medical

FDA Devices Moderate Mar 23, 2016

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

Sorin Group USA, Inc.

FDA Devices Moderate Mar 23, 2016

Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consistin…

Steris Corporation

FDA Devices Moderate Mar 23, 2016

Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COC…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A s…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FI…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTAT…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Pro-Dex Inc

FDA Devices Moderate Mar 23, 2016

Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY…

Zimmer Manufacturing B.V.

FDA Devices Moderate Mar 23, 2016

Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a b…

Covidien Medical Products (Shanghai) Manufacturing L.L.C.

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