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 |
|---|---|---|---|---|
| RemB | 6400034000 | ERL | 07613154938292 | 1557 |
| SmartLife | 7126-120-000 | HWE | 07613327128819 | 1010 |
| (unnamed) | 5450400000 | ERL | 07613252468356 | 772 |
| RemB | 6400015000 | ERL | 07613154938254 | 559 |
| (unnamed) | 5407-300-000 | ERL | 07613327177350 | 520 |
| Power-PRO | 6506 | FPO | 07613327261639 | 441 |
| (unnamed) | 5450040001 | ERL | 07613252468271 | 409 |
| (unnamed) | 5407100000 | ERL | 07613327096378 | 384 |
| StrykeFlow | 0250070500 | GCJ | 07613327061390 | 362 |
| RemB | 6400031000 | ERL | 07613154938308 | 360 |
| SERFAS Energy | 0279401200 | GEI | 07613327057034 | 355 |
| InTouch | 2141 | FNL | 07613327169232 | 324 |
| STRYKER | 7400-034-000 | ERL | 07613327482980 | 320 |
| 1688 | 1688010000 | GCJ | 07613327420081 | 288 |
| STRYKER | 7400-015-000 | ERL | 07613327483048 | 282 |
| StrykeFlow | 0250070520 | GCX | 07613327061369 | 273 |
| Crossfire | 0475100000 | GEI HRX | 07613327058109 | 270 |
| CORE Sumex | 5400130000 | ERL | 04546540534125 | 259 |
| RemB | 6400037000 | ERL | 07613154938339 | 256 |
| Prime Series | 1115 | FPO | 07613327278217 | 242 |
| L11 | 0220230300 | OWN | 07613327455915 | 236 |
| Prime Series | 1125 | INK | 07613327278286 | 226 |
| S3 | 3005 | FNL | 07613327278309 | 221 |
| (unnamed) | 5450040000 | ERL | 07613252468264 | 211 |
| SYNCHRO 14 | M00313010 | DQX | 07613252186922 | 203 |
| (unnamed) | 5100120472 | ERL | 04546540369970 | 200 |
| (unnamed) | 5450040003 | ERL | 07613252508106 | 198 |
| Prime Series | 1115 | FPO | 07613327278330 | 196 |
| Zyphr | 5100060001 | HBF | 04546540716224 | 191 |
| Prime Series | 1125 | INK | 07613327278293 | 187 |
Showing 1–30 of 36,412Next →
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 |
|---|---|---|---|---|
| 2936485 | STRYKER ENDOSCOPY | SAN JOSE, CA, US | VAI | |
| 3002807830 | STRYKER GmbH | SELZACH Solothurn, CH | VAI | |
| 3003164255 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION | CARRIGTWOHILL, CO.CORK Munster, IE | VAI | |
| 3002459190 | STRYKER IRELAND OSTEONICS | Cork Cork (County), IE | NAI | |
| 3002821504 | STRYKER LEIBINGER GMBH & CO. KG | FREIBURG Baden-Wurttemberg, DE | NAI | |
| 3007997036 | STRYKER MANUFACTURING KALAMAZOO | Portage, MI, US | NAI | |
| 1831750 | STRYKER MEDICAL | Portage, MI, US | VAI | |
| 2648666 | STRYKER PUERTO RICO, LLC. | ARROYO, PR, US | VAI | |
| 3002807231 | STRYKER TRAUMA GMBH | SCHOENKIRCHEN Schleswig-Holstein, DE | — | |
| 3007913880 | Stryker (Suzhou) Medical Technology Co.,Ltd. | Suzhou Jiangsu, CN | VAI | |
| 3013014058 | Stryker Anngrove | Cork Munster, IE | — | |
| 3012103978 | Stryker Endoscopy | Greenwood Village, CO, US | — | |
| 3015439135 | Stryker Endoscopy | Toronto Ontario, CA | — | |
| 3015967359 | Stryker Instruments | Portage, MI, US | VAI | |
| 3040335671 | Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork (County), IE | — | |
| 3008337808 | Stryker Macroom | Co Cork Munster, IE | NAI | |
| 3012931345 | Stryker Neurovascular | Salt Lake City, UT, US | NAI | |
| 3008853977 | Stryker Neurovascular | Fremont, CA, US | VAI | |
| 3008881809 | Stryker Neurovascular | Cork Munster, IE | — | |
| 3005596372 | Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | CHANGZHOU, JIANGSU, CN | VAI | |
| 3031800723 | Stryker Poland Manufacturing Sp. z o.o. | Skawina Malopolskie, PL | — | |
| 3009350690 | Stryker Sustainability Solutions | Tempe, AZ, US | NAI | |
| 3030153385 | Stryker Sustainability Solutions - Chandler | Chandler, AZ, US | — | |
| 1000132435 | Stryker Sustainability Solutions Lakeland | LAKELAND, FL, US | VAI | |
| 3002615969 | Stryker Sustainability Solutions Phoenix | Phoenix, AZ, US | NAI |