STRYKER CORPORATION
12690 adverse events · 1783 recalls · 273 clearances · 141 inspections · 5 compliance actions · aggregated across 6 source records
Scorecard
Events per device across the 36,412-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.048 ▼
1,750 in the last 12 months
Higher volume than 91% of companies with 10+ devices
Recalls per device
0.002 ▼
63 in the last 12 months
Higher volume than 98% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
36,412 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Neptune | 0703001000 | FYD JCX | 07613327116656 | 183 |
| SYNCHRO 2 | M00326410 | DQX | 04546540688767 | 173 |
| (unnamed) | 4100400000 | HWE | 04546540068323 | 167 |
| GoBed | FL28EX | FNL | 07613327169386 | 165 |
| (unnamed) | 5100120470 | ERL | 04546540369963 | 165 |
| (unnamed) | 5407-FA2-000 | HBE | 07613327096392 | 163 |
| (unnamed) | 5100120482 | ERL | 04546540369994 | 161 |
| (unnamed) | 1089 | FPO | 07613327278170 | 161 |
| Altrix | 8001 | DWJ FLL | 07613327277555 | 155 |
| Neptune | 0703046000 | GEI | 07613327117189 | 153 |
| (unnamed) | 5407FA2023 | HBE | 07613327096729 | 144 |
| (unnamed) | 5400121000 | ERL | 04546540402028 | 143 |
| AXSOS | 702753 | LXH | 07613327005028 | 142 |
| InTouch | 2141 | FNL | 07613327385427 | 142 |
| (unnamed) | 5407-120-450 | HBE | 07613327096545 | 141 |
| COBRA | 3910900093 | NBH | 07613327413595 | 138 |
| Stryker SmartLife | 7222120000 | HWE | 07613327128789 | 136 |
| s3 | 3005 | FNL | 07613327278347 | 135 |
| Neptune | 0703047000 | GEI | 07613327117202 | 134 |
| CUB | FL19H | FMS | 07613327169348 | 125 |
| (unnamed) | 5100015250 | EIA | 04546540380272 | 123 |
| PRO | 703966 | LXH | 07613252719861 | 123 |
| (unnamed) | 5407-120-472 | HBE | 07613327096576 | 122 |
| (unnamed) | 4100062000 | HWE | 04546540068354 | 120 |
| Excelsior SL-10 | M0031681890 | DQY | 04546540688217 | 119 |
| GoBed | FL28C | FNL | 07613327169355 | 119 |
| REUNION | 5901-1168 | KWS | 07613327101027 | 119 |
| (unnamed) | 5407-120-482 | HBE | 07613327096590 | 118 |
| (unnamed) | 4701 | HDD | 07613327278095 | 117 |
| XIA 3 | 48230000 | KWP MNH MNI NKB OSH | 04546540560193 | 117 |
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3033273526 | Artelon | ATL, GA, US | — | |
| 3006125657 | BERCHTOLD GMBH & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE | — | |
| 3003897776 | BIOMIMETIC THERAPEUTICS,LLC | FRANKLIN, TN, US | VAI | |
| 3006345872 | Entellus Medical, Inc | Plymouth, MN, US | OAI | |
| 3004123209 | HEARTSINE TECHNOLOGIES, LTD | BELFAST Northern Ireland, GB | NAI | |
| 3002807172 | HOWMEDICA INTERNATIONAL S. DE R.L., | LIMERICK Munster, IE | NAI | |
| 3003070421 | HOWMEDICA OSTEONICS CORP | MAHWAH, NJ, US | VAI | |
| 3005920920 | HYPERBRANCH MEDICAL TECHNOLOGY INC | Durham, NC, US | NAI | |
| 3014027736 | IMASCAP | PLOUZANE Finistere, FR | — | |
| 3010673515 | INTERNATIONAL LIFE SCIENCES | Sandy Springs, GA, US | NAI | |
| 3040801290 | Inari Medical, Costa Rica S.A. | Grecia Alajuela, CR | — | |
| 3020347218 | Inari Medical, Inc. | Irvine, CA, US | — | |
| 3005445717 | JOLIFE AB | LUND Skane, SE | NAI | |
| 3023527320 | LimFlow Inc. | Irvine, CA, US | VAI | |
| 3005985723 | MAKO SURGICAL CORP. | Weston, FL, US | VAI | |
| 3010151377 | MOBIUS IMAGING, LLC | Shirley, MA, US | VAI | |
| 3007456622 | NICO CORPORATION | Indianapolis, IN, US | VAI | |
| 3012345110 | Novadaq Technologies ULC | Burnaby British Columbia, CA | VAI | |
| 3016573902 | Ortho-Space Ltd. | Caesarea Haifa, IL | — | |
| 3015876 | PHYSIO-CONTROL, INC. | Redmond, WA, US | NAI | |
| 3010411911 | POM Medical, LLC | Moorpark, CA, US | NAI | |
| 3008668801 | SERF | DECINES CHARPIEU Rhone, FR | NAI | |
| 3002975342 | STRYKER Communications, Inc. | Flower Mound, TX, US | NAI | |
| 1811755 | STRYKER CORP. | KALAMAZOO, MI, US | NAI | |
| 3008837339 | STRYKER EMEA Supply Chain Services | Venlo Limburg, NL | — |
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