Indiana recalls
2374 federal recalls on file affecting Indiana - 149 Indiana-specific plus 2225 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck your GEM Premier 5000 PAK cartridges
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck your GEM Premier 5000 PAK lot number
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck Instrumentation Laboratory GEM Premier 5000 PAK cartridges
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck your GEM Premier 5000 PAK lot number
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck your GEM Premier 5000 PAK lot number
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceInstrumentation LaboratoryClass IINationwideCheck GEM Premier 5000 PAK cartridge lot numbers
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using Waldemar Link Endo-Model Replacement Plateau
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck Endo-Model Replacement Plateau implants
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck your Endo-Model Replacement Plateau implant
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using Waldemar Link Endo-Model Plateau screw
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using affected Waldemar Link plateau screws
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck your Endo-Model Replacement Plateau implant
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using affected Waldemar Link plateau screws
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideContact your surgeon about Waldemar Link plateau screw
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck Waldemar Link knee implant screw
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck Endo-Model SL implant lot numbers
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideCheck Waldemar Link implant screw lot numbers
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using Waldemar Link Endo-Model Plateau screws
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar LinkClass IINationwideStop using affected Waldemar Link implant components
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceExactechClass IIStop using Exactech Equinoxe instrument kits
Impactor handle may be missing cross-pin
- 2026-03-18FDA-DeviceExactechClass IIStop using Exactech Equinoxe Ergo impactor handles
Impactor handle may be missing cross-pin
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa model
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa model number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwidePenner Pacific Bathing Spa, Model Numbers 360020-1EP
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient CareClass IIINationwideCheck your Penner Pacific Bathing Spa serial number
The device does not bear a unique device identifier.
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