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 |
|---|---|---|---|---|
| Connected OR Hub | 0240200100 | GCJ HRX | 07613327413281 | 116 |
| (unnamed) | 5051 | FPO | 07613327278361 | 116 |
| (unnamed) | 5407-120-950C | HBE | 07613327096491 | 116 |
| CinchLock | CAT02462 | MBI | 07613252633228 | 115 |
| (unnamed) | 5450040002 | ERL | 07613252508090 | 115 |
| Gynnie | 1061 | FPO | 07613327278200 | 114 |
| STRYKER | 7400-031-000 | ERL | 07613327482973 | 112 |
| Maestro | 5400210058 | ERL | 04546540469205 | 110 |
| (unnamed) | 8208000000 | HWE | 07613327304541 | 110 |
| (unnamed) | 8205000000 | HWE OLO | 07613327304466 | 110 |
| Power-LOAD | 6390 | FPO | 07613327261523 | 110 |
| ProCuity | 300900000000 | FNL | 07613327512656 | 110 |
| S3 | 3005 | FNL | 07613327278422 | 110 |
| (unnamed) | 5407-120-470 | HBE | 07613327096569 | 107 |
| Prime Series | 1105 | FPO | 07613327278156 | 105 |
| Power-PRO 2, High Configuration | 650705550001 | FPO | 07613327559118 | 104 |
| Maestro Air | 5407-200-000 | HBB | 07613327096460 | 103 |
| Synchro SELECT | SSFT215STR | DQX MOF | 07613327508574 | 103 |
| Formula | 0375544000 | GFA | 07613327061789 | 101 |
| L9000 | 0220210000 | FCW | 07613327051339 | 101 |
| (unnamed) | 0277096325 | GFA | 04546540051783 | 101 |
| GAMMA | 1320-0111 | HSB | 04546540716774 | 100 |
| (unnamed) | 5407-120-050 | HBE | 07613327096651 | 100 |
| Prime TC | 1460-000-000 | INN | 07613327282665 | 100 |
| Synchro SELECT | SSTD215STR | DQX MOF | 07613327508499 | 100 |
| RemB | 6400099000 | ERL | 07613154938353 | 99 |
| Neptune | 0703047002 | GEI | 07613327379471 | 98 |
| (unnamed) | 8206000000 | HWE | 07613327304473 | 97 |
| CrossFlow | 0450000000 | HRX | 07613327058048 | 96 |
| (unnamed) | 7206000000 | HWE | 07613327064834 | 94 |
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 |