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 |
|---|---|---|---|---|
| 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 |